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Biomedical subjects

Jonathan M Holmes

Publications and source records attributed to Jonathan M Holmes.

At least 19 recordsLinked to original sources

A symptom survey and quality of life questionnaire for nasolacrimal duct obstruction in children.

PURPOSE: To develop and validate a new parental questionnaire addressing symptoms and health-related quality of life (HRQL) in childhood nasolacrimal duct obstruction (NLDO). DESIGN: Cross-sectional study. PARTICIPANTS: Children ages 6 to younger than 48 months with and without clinical signs of NLDO. METHODS: A new questionnaire was developed using semistructured interviews with parents of children with NLDO and through discussions with expert clinicians. Questionnaires were completed by parents of children with and without NLDO. Cronbach's alpha was calculated as a measure of internal-consistency reliability. Factor analysis was used to evaluate a priori subscales: symptoms and HRQL. Discriminant construct validity was assessed by comparing questionnaire scores between children with and without NLDO and between affected and unaffected eyes of children with unilateral NLDO. Instrument responsiveness was determined by comparing presurgical and postsurgical intervention scores in a subset of NLDO patients who underwent surgical treatment. MAIN OUTCOME MEASURE: The NLDO questionnaire score. RESULTS: Eighty-seven children were enrolled, 56 with and 31 without NLDO. All but 2 questions on the questionnaire showed a good distribution of responses, a high correlation with the rest of the questionnaire, and excellent discrimination between patients with and without NLDO. Cronbach's alpha values were good for the overall questionnaire (0.95), and for 2 predetermined subscales: symptoms (0.95) and HRQL (0.85). On a 0 to 4 scale, NLDO patients had worse scores compared with non-NLDO patients for both symptoms (mean difference, 2.1; 95% confidence interval [CI], 1.9-2.3) and HRQL (mean difference, 1.2; 95% CI, 0.9-1.5) subscales. The NLDO patients had worse scores before intervention compared with after intervention for both the symptoms (mean difference, 2.2; 95% CI, 1.6-2.9) and HRQL (mean difference, 1.4; 95% CI, 0.8-2.1) subscales. Finally, NLDO patients had worse symptom scores for affected eyes compared with unaffected eyes (mean difference, 2.3; 95% CI, 1.9-2.6). CONCLUSIONS: This novel NLDO questionnaire is useful in quantifying parental perception of symptoms and HRQL in childhood NLDO. The questionnaire may have a role in future clinical studies of NLDO.

Child, Preschool↗

Amblyopia.

Results from recent randomised clinical trials in amblyopia should change our approach to screening for and treatment of amblyopia. Based on the current evidence, if one screening session is used, screening at school entry could be the most reasonable time. Clinicians should preferably use age-appropriate LogMAR acuity tests, and treatment should only be considered for children who are clearly not in the typical range for their age. Any substantial refractive error should be corrected before further treatment is considered and the child should be followed in spectacles until no further improvement is recorded, which can take up to 6 months. Parents and carers should then be offered an informed choice between patching and atropine drops. Successful patching regimens can last as little as 1 h or 2 h a day, and successful atropine regimens as little as one drop twice a week. Intense and extended regimens might not be needed in initial therapy.

Amblyopia↗

Real depth vs randot stereotests.

PURPOSE: To compare the performance of real depth and Randot stereotests in strabismic and nonstrabismic patients. DESIGN: Observational case series. METHODS: Stereoacuity was tested in 182 patients with a variety of strabismic conditions, using the Frisby-Davis 2 (FD2) distance stereotest, the near Frisby (nF) (both real depth tests), the Preschool Randot (nR), and Distance Randot (dR) tests (both based on Polaroid vectographs). RESULTS: Patients appreciated finer disparities with the nF test than the nR test at near and with the FD2 test than the dR test at distance. CONCLUSIONS: The type of stereotest influences measurable thresholds, and the results from different tests are not interchangeable. The choice of test should depend on the question being asked; nF and FD2 would be appropriate for determining presence or absence of stereopsis and best measurable stereopsis. The more rigorous Randot tests would be appropriate for determining subtle changes.

Adolescent↗

Assessment of a new Distance Randot stereoacuity test.

PURPOSE: We sought to develop a new "Distance Randot" test, establish a normative data set for children and adults, and compare with established measures of stereoacuity. METHODS: Distance Randot, distance Frisby-Davis 2 (FD2), and near Preschool Randot stereoacuity (Stereo Optical Co., Inc., Chicago, IL) were assessed in 23 normal children (ages 4-14 years), 21 normal adults (ages 20-36 years), and 131 patients with a variety of strabismic conditions (ages 4-85 years). For each test, stereoacuity was defined as the smallest disparity in which 2 targets were correctly identified. The simultaneous prism and cover test (SPCT) and the alternate prism and cover test (APCT) were used to assess misalignment. RESULTS: For the new Distance Randot test, normative results were similar to published data obtained with established near and distance stereoacuity tests. In the patient cohort, comparing stereoacuity data obtained from Distance Randot stereoacuity test and the Near Preschool Randot stereoacuity test, most of the patients with discordant scores had poorer distance than near stereoacuity. Comparing the Distance Randot stereoacuity test and the Distance FD2, all of the patients with discordant scores had poorer Distance Randot than FD2 scores. CONCLUSIONS: Distance Randot test is more likely to detect abnormalities in distance stereopsis and may provide a useful tool in measuring distance stereoacuity in patients with and without strabismus. However, further studies are needed to define the efficacy of the Distance Randot test in monitoring progression specific conditions such as intermittent exotropia, where it may prove useful as a guide to the timing of intervention.

Adolescent↗

Treatment of anisometropic amblyopia in children with refractive correction.

OBJECTIVE: To evaluate the effectiveness of refractive correction alone for the treatment of untreated anisometropic amblyopia in children 3 to <7 years old. DESIGN: Prospective, multicenter, noncomparative intervention. PARTICIPANTS: Eighty-four children 3 to <7 years old with untreated anisometropic amblyopia ranging from 20/40 to 20/250. METHODS: Optimal refractive correction was provided, and visual acuity (VA) was measured with the new spectacle correction at baseline and at 5-week intervals until VA stabilized or amblyopia resolved. MAIN OUTCOME MEASURES: Maximum improvement in best-corrected VA in the amblyopic eye and proportion of children whose amblyopia resolved (interocular difference of < or =1 line) with refractive correction alone. RESULTS: Amblyopia improved with optical correction by > or =2 lines in 77% of the patients and resolved in 27%. Improvement took up to 30 weeks for stabilization criteria to be met. After stabilization, additional improvement occurred with spectacles alone in 21 of 34 patients observed in a control group of a subsequent randomized trial, with amblyopia resolving in 6. Treatment outcome was not related to age, but was related to better baseline VA and lesser amounts of anisometropia. CONCLUSION: Refractive correction alone improves VA in many cases and results in resolution of amblyopia in at least one third of 3- to <7-year-old children with untreated anisometropic amblyopia. Although most cases of resolution occur with moderate (20/40-20/100) amblyopia, the average 3-line improvement in VA resulting from treatment with spectacles may lessen the burden of subsequent amblyopia therapy for those with denser levels of amblyopia.

Amblyopia↗

A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children.

OBJECTIVE: To compare 2 hours of daily patching (combined with 1 hour of concurrent near visual activities) with a control group of spectacle wear alone (if needed) for treatment of moderate to severe amblyopia in children 3 to 7 years old. DESIGN: Prospective randomized multicenter clinical trial (46 sites). PARTICIPANTS: One hundred eighty children 3 to 7 years old with best-corrected amblyopic-eye visual acuity (VA) of 20/40 to 20/400 associated with strabismus, anisometropia, or both who had worn optimal refractive correction (if needed) for at least 16 weeks or for 2 consecutive visits without improvement. INTERVENTION: Randomization either to 2 hours of daily patching with 1 hour of near visual activities or to spectacles alone (if needed). Patients were continued on the randomized treatment (or no treatment) until no further improvement was noted. MAIN OUTCOME MEASURE: Best-corrected VA in the amblyopic eye after 5 weeks. RESULTS: Improvement in VA of the amblyopic eye from baseline to 5 weeks averaged 1.1 lines in the patching group and 0.5 lines in the control group (P = 0.006), and improvement from baseline to best measured VA at any visit averaged 2.2 lines in the patching group and 1.3 lines in the control group (P<0.001). CONCLUSION: After a period of treatment with spectacles, 2 hours of daily patching combined with 1 hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.

Amblyopia↗

The relationship of retinal VEGF and retinal IGF-1 mRNA with neovascularization in an acidosis-induced model of retinopathy of prematurity.

PURPOSE: Acidosis-induced retinopathy (AIR) in the neonatal rat provides an alternative model for retinopathy of prematurity (ROP). We studied the relationship of vascular endothelial growth factor (VEGF) retinal mRNA and insulin-like growth factor-1 (IGF-1) retinal mRNA expression with the emergence of neovascularization (NV) in AIR. METHODS: Two hundred seventy-five newborn Sprague-Dawley rats were raised in 11 expanded litters of 25. Using our established AIR model, acidosis was induced by twice-daily gavage with NH4Cl from day 2 to day 8 of life (n=175). Rats were sacrificed at days 5, 8, and 10. Nongavaged rats were used as age-matched controls (n=100). Retinae from left eyes were dissected, flatmounts were ADPase-stained, and the presence and severity of NV was scored in a masked manner. Individual right retinae were processed for analysis of retinal VEGF and IGF-1 mRNA using quantitative real-time reverse-transcriptase PCR (qRT-PCR). RESULTS: Retinal VEGF mRNA was increased 1.4-fold at day 10 in AIR, when compared with age-matched controls (p=0.03). This correlated with maximal NV at day 10 in AIR. Retinal IGF-1 mRNA was decreased to 82% of its normal expression on day 8 (p=0.006), prior to maximal NV, before returning to normal expression at day 10, when compared with nonacidotic controls. CONCLUSIONS: In AIR, preretinal neovascularization is associated with decreased retinal IGF-1 mRNA prior to maximal NV and increased retinal VEGF mRNA at the time of maximal NV. These growth factor changes in AIR are similar to those seen with hypercarbic oxygen-induced retinopathy. The retinal IGF-1 pathway may provide an alternative target for therapeutic intervention in abnormal retinal angiogenesis.

Acidosis↗

The treatment of amblyopia.

Recent studies suggest that children with amblyopia associated with anisometropia, strabismus, or both should be treated initially with best refractive correction until visual acuity is stable. This may take several months, and a proportion of children will achieve equal visual acuity with glasses alone. For residual anisometropic and strabismic amblyopia, the initial choice of patching or atropine should involve the parent and the child. The dose of prescribed patching or atropine may initially be quite modest, such as 2 hours of patching a day or twice weekly atropine. Treatment should be offered to children until at least 12 years of age and possibly to teenagers. Ongoing studies are addressing the role of undertaking near activities while patched and the role of atropine for severe amblyopia and for older amblyopic children. Future studies are needed to investigate the best treatment strategies for residual amblyopia, whether weaning treatment is needed at the end of a course, and how compliance can be enhanced.

Amblyopia↗

An office-based scale for assessing control in intermittent exotropia.

INTRODUCTION: Although intermittent exotropia may deteriorate with time, there are no widely accepted criteria for measuring progression in this disorder. The purpose of this study was to prospectively evaluate a new scale for assessing the level of control in children with intermittent exotropia. METHODS: Thirty consecutive pediatric patients (< 14 years) with intermittent exotropia were prospectively evaluated from July 1, 2004 through June 30, 2005 using a new scale to assess the level of control for both distance and near fixation. The distance score (0 to 5) was combined with the near score (0 to 5) to yield an overall control score from 0 to 10. RESULTS: The 30 patients were examined at a median age of 72 months (range, 15 months to 13 years). The level of control at distance was worse than or equal to the near level of control in all 30 patients. The control scores ranged from 0 to 5 for distance and 0 to 4 for near, with an overall control score ranging from 0 to 8 (median of 3). CONCLUSIONS: This new scale for assessing control in children with intermittent exotropia can be easily applied in the office setting and characterizes the wide range of control in this disorder.

Adolescent↗

Anti-thyroid methimazole in an acidosis-induced retinopathy rat model of retinopathy of prematurity.

PURPOSE: Methimazole (MMI), an anti-thyroid drug known to reduce serum levels of L-thyroxine (T4) and insulin-like growth factor-1 (IGF-1), has been previously reported to increase the incidence of neovascularization (NV) in an oxygen-induced retinopathy (OIR) model of retinopathy of prematurity (ROP) in rats. We investigated the effect of MMI on the incidence and severity of NV in a non-oxygen-induced model of ROP, acidosis-induced retinopathy (AIR). METHODS: Newborn Sprague Dawley rats were raised in expanded litters of 25 in room air for four or ten days under one of the two following conditions: (1) Our established model of AIR (acidosis via NH4Cl gavage (10 mmol/kg) twice daily from days 2 to 7, followed by two days of recovery) or (2) MMI (given as a 0.1% solution to nursing mothers) in the above AIR model. Left eyes were fixed, and retinas were dissected and ADPase-stained. Flat mounted retinas were graded in a masked manner for presence and severity of NV, and retinal vascular areas were quantified. Serum IGF-1 and T4 concentrations were measured by radioimmunoassay on days 4 and 10. Arterial blood pH measurements were performed on day 4. RESULTS: The incidence and severity of NV were similar between AIR and MMI-AIR rats (incidence: 24% and 33%). Serum IGF-1 concentrations in 10 day MMI-AIR rats were significantly lower than untreated non-acidotic controls (medians: 158 ng/ml and 207 ng/ml; p=0.03). Serum IGF-1 concentrations were similar between 10 day AIR rats and untreated non-acidotic controls (medians: 189 ng/ml and 207 ng/ml; p>0.9). CONCLUSIONS: MMI does not increase the incidence or severity of NV in an AIR neonatal rat model of ROP. Although serum IGF-1 has been considered permissive for NV in immature retinas, supranormal concentrations of serum IGF-1 may not be necessary for abnormal retinal angiogenesis. Further studies are warranted on the roles of serum IGF-1 and L-thyroxine in the pathogenesis of ROP.

Acidosis↗

New methods for quantifying diplopia.

PURPOSE: To develop new methods for quantifying diplopia and test their validity, test-retest reliability, and responsiveness to treatment. DESIGN: Prospective case series. PARTICIPANTS: Adult patients with diplopia in 2 tertiary referral practices. Diagnosis included cranial nerve palsies, thyroid eye disease, supranuclear palsies, and ocular myasthenia gravis. METHODS: The new diplopia questionnaire and cervical range of motion (CROM) diplopia examination were tested in a 15-patient validity study against the standard diplopia field performed on the Goldmann perimeter (each scored 0 [no diplopia] to 100 [constant diplopia in all fields]). The test-retest reliability of the CROM diplopia examination was determined in 27 patients. The responsiveness to treatment of the diplopia questionnaire and the CROM examination was tested in 15 patients who underwent strabismus surgery or received systemic prednisone for ocular myasthenia gravis. MAIN OUTCOME MEASURES: Validity was evaluated by the intraclass correlation coefficient (ICC) compared with the standard Goldmann diplopia field. Test-rest reliability was evaluated by the ICC. Responsiveness to treatment was evaluated by comparing pretreatment and posttreatment scores. RESULTS: There was excellent agreement between the diplopia questionnaire score and Goldmann diplopia field score (ICC, 0.90) and between the CROM diplopia examination score and Goldmann diplopia field score (ICC, 0.88). Intertester reliability of the CROM diplopia examination score was excellent (ICC, 0.87; 95% confidence interval, 0.74-0.94). Postintervention scores were significantly lower than baseline (P = 0.0003 for CROM and P = 0.0001 for the questionnaire), with a median postintervention improvement of 48 for the CROM diplopia score (quartiles 12-68) and 36 for the diplopia questionnaire (quartiles 20-52). CONCLUSIONS: Our new diplopia questionnaire and new CROM diplopia examination are valid, reliable, and responsive measures of diplopia severity. The tests are easy to administer and require less expensive and less cumbersome equipment than previously available.

Adult↗

Differences between rat strains in models of retinopathy of prematurity.

PURPOSE: Genetic factors appear to modulate the incidence and severity of retinopathy of prematurity (ROP). Different rat strains may be analogous to genetic differences across human ethnic groups. We investigated the incidence and severity of neovascularization (NV) in Brown Norway (BN) and Sprague Dawley (SD) rats in oxygen-induced retinopathy (OIR) and acidosis-induced retinopathy (AIR) models for ROP. We also studied whether there was a difference in retinal vascular endothelial growth factor (VEGF) mRNA levels in OIR animals. METHODS: Newborn SD and BN rats (110 in both groups) were raised in standardized litters of ten (four OIR, twelve AIR, six non-gavaged room air controls). Beginning on day 1 of life, OIR litters were exposed to seven cycles of hyperoxia (80% O2, 20.5 h) and hypoxia (10% O2, 0.5 h) with a gradual return to 80% O2 over 3 h. This was followed by room air recovery for five days. OIR and OIR control rats were sacrificed on day 13 of life. AIR rats were gavaged twice daily with NH4Cl (10 mmol/kg) from day 2 to day 7 of life, or 15 mmol/kg twice daily on day 2 and then 10 mmol/kg twice daily from day 3 to day 7. AIR and AIR control rats were sacrificed on day 10 or day 13. Retinas from left eyes were dissected, ADPase stained and flatmounted. Presence and severity of NV (clock hours, 0 to 12) was scored by a masked observer. Right retinas from OIR and room air controls were processed for VEGF mRNA analysis. RESULTS: In OIR rats, the incidence of NV was higher in BN than SD rats (100% compared to 5%, p<0.0001). NV was more severe in BN rats (1 to 10 clock hours, median 7 clock hours compared to 0 to 1 clock hours, p=0.0001). In contrast, the incidence of NV in AIR rats was similar in BN and SD rats (4% compared to 0%, p=1.0) in the 10 mmol/kg study, and 18% compared to 0%, (p= 0.15) in the 15 mmol/kg study. Increased levels of retinal VEGF mRNA were found in BN OIR animals when compared to BN room air controls (1.4 fold increase) whereas retinal VEGF mRNA levels were similar between SD OIR and SD room air control animals. CONCLUSIONS: BN rats differ from SD rats in incidence and severity of NV in OIR. The findings in AIR were limited by the low incidence of NV and intolerance to higher multiple doses of NH4Cl. In OIR, the higher severity of NV was associated with higher retinal VEGF mRNA in BN OIR rats. Studies are warranted to investigate the genetic differences between Brown Norway and Sprague Dawley rats in models of ROP. These genetic studies may yield further clues into the pathogenesis of clinical ROP.

Acid-Base Equilibrium↗

Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children.

OBJECTIVE: To compare patching and atropine sulfate as treatments for moderate amblyopia in children 18 months after completion of a 6-month randomized trial. METHODS: In a randomized, multicenter (47 sites) clinical trial, 419 children younger than 7 years with amblyopia (20/40 to 20/100 in the affected eye) were assigned to receive either patching or atropine eye drops for 6 months. Between 6 months and 2 years, treatment was at the discretion of the investigator. Main Outcome Measure Visual acuity in the amblyopic eye and sound eye after 2 years. RESULTS: At 2 years, visual acuity in the amblyopic eye improved from baseline a mean of 3.7 lines in the patching group and 3.6 lines in the atropine group. The difference in visual acuity between treatment groups was small: 0.01 logMAR (95% confidence interval, -0.02 to 0.04). In both treatment groups, the mean amblyopic eye acuity was approximately 20/32, 1.8 lines worse than the mean sound eye acuity, which was approximately 20/20. CONCLUSIONS: Atropine or patching for 6 months followed by best clinical care until 2 years produced similar improvement of moderate amblyopia in children between 3 and 7 years of age at enrollment. However, on average the amblyopic eye acuity was still approximately 2 lines worse than the sound eye.

Amblyopia↗

Randomized trial of treatment of amblyopia in children aged 7 to 17 years.

OBJECTIVE: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years. METHODS: At 49 clinical sites, 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group (2-6 hours per day of prescribed patching combined with near visual activities for all patients plus atropine sulfate for children aged 7 to 12 years) or an optical correction group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (> or =2 lines) by 24 weeks were considered responders. RESULTS: In the 7- to 12-year-olds (n = 404), 53% of the treatment group were responders compared with 25% of the optical correction group (P<.001). In the 13- to 17-year-olds (n = 103), the responder rates were 25% and 23%, respectively, overall (adjusted P = .22) but 47% and 20%, respectively, among patients not previously treated with patching and/or atropine for amblyopia (adjusted P = .03). Most patients, including responders, were left with a residual visual acuity deficit. CONCLUSIONS: Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years, although most patients who are initially treated with optical correction alone will require additional treatment for amblyopia. For patients aged 7 to 12 years, prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated. For patients 13 to 17 years, prescribing patching 2 to 6 hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated but appears to be of little benefit if amblyopia was previously treated with patching. We do not yet know whether visual acuity improvement will be sustained once treatment is discontinued; therefore, conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study we are conducting on the patients who responded to treatment.

Adolescent↗

Testing distance stereoacuity with the Frisby-Davis 2 (FD2) test.

PURPOSE: To develop a presentation protocol for the new Frisby-Davis 2 (FD2) distance stereoacuity test. DESIGN: Prospective data collection. METHODS: Stereoacuity was tested monocularly and binocularly in 95 patients with a variety of strabismic and nonstrabismic conditions, using the FD2, employing a modified staircase procedure. The Preschool Randot Stereoacuity test and the near Frisby test were used to determine whether a patient was stereoblind. RESULTS: Under monocular conditions, 35 (37%) of 95 patients passed at least the largest disparity of the FD2 indicating a problem with monocular cues. The binocular protocol was then modified to include a monocular test phase. Using the new protocol, if a patient could achieve the same stereoacuity under monocular and binocular conditions, they were deemed to have no stereopsis. Testing 28 additional stereoblind patients using the new modified protocol revealed no false positives. CONCLUSION: The FD2 stereotest is a useful measure of distance stereoacuity, provided the presentation protocol accounts for monocular cues.

Adolescent↗

A randomized pilot study of near activities versus non-near activities during patching therapy for amblyopia.

BACKGROUND: To plan a future randomized clinical trial, we conducted a pilot study to determine whether children randomized to near or non-near activities would perform prescribed activities. A secondary aim was to obtain a preliminary estimate of the effect of near versus non-near activities on amblyopic eye visual acuity, when combined with 2 hours of daily patching. METHODS: Sixty-four children, 3 to less than 7 years of age, with anisometropic, strabismic, or combined amblyopia (20/40 to 20/400) were randomly assigned to receive either 2 hours of daily patching with near activities or 2 hours of daily patching without near activities. Parents completed daily calendars for 4 weeks recording the activities performed while patched and received a weekly telephone call in which they were asked to describe the activities performed during the previous 2 hours of patching. Visual acuity was assessed at 4 weeks. RESULTS: The children assigned to near visual activities performed more near activities than those assigned to non-near activities (by calendars, mean 1.6 +/- 0.5 hours versus 0.2 +/- 0.2 hours daily, P < 0.001; by telephone interviews, 1.6 +/- 0.4 hours versus 0.4 +/- 0.5 hours daily, P < 0.001). After 4 weeks of treatment, there was a suggestion of greater improvement in amblyopic eye visual acuity in those assigned to near visual activities (mean 2.6 lines versus 1.6 lines, P = 0.07). The treatment group difference in visual acuity was present for patients with severe amblyopia but not moderate amblyopia. CONCLUSIONS: Children patched and instructed to perform near activities for amblyopia spent more time performing those near activities than children who were instructed to perform non-near activities. Our results suggest that performing near activities while patched may be beneficial in treating amblyopia. Based on our data, a formal randomized amblyopia treatment trial of patching with and without near activities is both feasible and desirable.

Activities of Daily Living↗

The effect of amblyopia therapy on ocular alignment.

PURPOSE: We sought to describe the change in ocular alignment at 2 years after treatment of amblyopia in children younger than 7 years of age at enrollment. METHODS: A randomized clinical trial of patching versus atropine for 6 months followed by standard clinical care for 18 months was conducted in 357 children with anisometropic, strabismic, or combined amblyopia (20/40-20/100) whose ages ranged from 3 to younger than 7 years at enrollment. Ocular alignment was evaluated at enrollment and after 2 years of follow-up. RESULTS: At enrollment when tested at distance fixation, 161 (45%) children were orthotropic, 91 (25%) had a microtropia (1-8 Delta), and 105 (29%) had a heterotropia >8 Delta. Of the 161 patients with no strabismus, similar proportions of patients initially assigned to the patching and atropine groups developed new strabismus by 2 years (18% vs. 16%, P = 0.84). Of these cases of new strabismus, only 2 patients in the patching group and 3 patients in the atropine group developed a deviation that was greater than 8 Delta. Microtropia at enrollment progressed to a deviation greater than 8 Delta with similar frequency in both treatment groups (13% vs. 15%, P = 1.00). Of the 105 patients with strabismus greater than 8 Delta at enrollment, 13% of those in the patching group and 16% of those in the atropine group improved to orthotropia without strabismus surgery. Strabismus surgery was performed in 32 patients during the 2-year study period. CONCLUSIONS: Patients who had amblyopia treatment with patching or atropine for 6 months followed by standard clinical care were found to have similar rates of deterioration and improvement of ocular alignment. When parents begin amblyopia treatment for children without strabismus, they should be warned of the possibility of development of strabismus, although it is most often a small angle deviation. Strabismus resolved after amblyopia therapy in some cases.

Amblyopia↗