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Biomedical subjects

D D Koch

Publications and source records attributed to D D Koch.

At least 19 recordsLinked to original sources

A prospective multicenter clinical trial to evaluate the safety and effectiveness of the implantable miniature telescope.

PURPOSE: To evaluate the safety and preliminary efficacy of a novel visual prosthetic device, the Implantable Miniature Telescope, IMT (by Dr Isaac Lipshitz) (IMT), in a phase I trial in patients with significant bilateral central vision impairment from late-stage age-related macular degeneration (AMD). The IMT is designed to reduce the relative size of the scotoma by rendering enlarged (threefold) central visual field images over the central and peripheral retina. DESIGN: Prospective, multicenter, open-label clinical trial. METHODS: In this prospective, multicenter phase I trial, 14 patients aged 60 or older with bilateral geographic atrophy or disciform scar AMD, cataract, and best-corrected visual acuity (BCVA) between 20/80 and 20/400 had an IMT implanted in one eye. Distance and near BCVA, endothelial cell density, and quality of life, measured as activities of daily life (ADL), were evaluated preoperatively and postoperatively. RESULTS: At 12 months, 10 (77%) of 13 patients gained 2 more lines of either distance or near BCVA, and eight (62%) of 13 patients gained 3 or more lines in either distance or near BCVA. Mean endothelial cell density decreased by 13%. All adverse events resolved without sequelae. ADL scores improved in the majority of patients. CONCLUSION: The results of this phase I trial support further evaluation of the IMT in a larger study population with late-stage AMD. A phase II/III trial is in progress.

Activities of Daily Living↗

Intrastromal corneal ring segments for low myopia: a report by the American Academy of Ophthalmology.

OBJECTIVE: This document describes intrastromal corneal ring segments (Intacs) inserts technology and examines the evidence to answer the key question about whether the treatment is safe and effective in correcting low myopia. METHODS: A literature search that was conducted in September 2000 retrieved 13 relevant citations, and the reference lists of these articles were consulted for additional citations. Panel members reviewed this information and articles were rated according to the strength of evidence. RESULTS: Prospective multicenter phase II and III clinical trials (Level II evidence rating) of Intacs inserts for myopia of -1.00 to -3.00 diopters (D), with a maximum of +1.00 D of astigmatism, enrolled a total of 452 subjects, with a total of 454 surgical attempts. The results from phase II and phase III were pooled for much of the analysis. At 1 year, 97% of patients who completed follow-up had 20/40 or better uncorrected visual acuity (UCVA). Seventy-four percent of patients had 20/20 or better UCVA. Ninety-two percent of eyes were within +/-1 D of intended refractive correction, and 69% were within 0.5 D of intended refractive correction. At 3 months, 90% of patients had less than 1.0 D of change from the previous examination performed at 1 month. The ocular complication rate, which was defined as clinically significant events but not resulting in permanent sequelae, was 11% at 12 months. The adverse event rate was 1.1%, defined as a serious event if untreated. Nearly 9% of patients requested to have their inserts removed and a total of 3.8% of patients required a secondary surgical intervention. CONCLUSIONS: To date, evidence suggests that low myopia (-1 to -3 D) in a well-defined group of patients who have a stable manifest refraction and less than +1.0 D of astigmatism can be treated with Intacs inserts with a reasonable assurance of safety and effectiveness. Additional clinical research is needed to determine the long-term effectiveness of treatment and the comparative safety, effectiveness, and costs with other treatment modalities, including laser-assisted in-situ keratomileusis (LASIK) and photorefractive keratectomy (PRK).

Academies and Institutes↗

Comparison of changes in manifest refraction and corneal power after photorefractive keratectomy.

PURPOSE: To determine which corneal curvature values most closely correlate to change in manifest refraction after excimer laser photorefractive keratectomy. METHODS: In a prospective study at the Cullen Eye Institute, excimer laser photorefractive keratectomy was performed on 27 eyes of 27 patients (mean age, 38.07+/-6.65 years). Preoperative refractive errors ranged from -2.25 diopters to -8.75 diopters (mean, -5.74+/-2.09 diopters). Preoperatively and 1 month postoperatively, we determined the spherical equivalent of the subjective manifest refraction (corrected for a 12-mm vertex distance) and measured corneal power using standard keratometry (Bausch & Lomb Keratometer; Rochester, New York) and computerized videokeratography (EyeSys Corneal Analysis System; Premier Laser Systems Inc, Houston, Texas). We collected 15 corneal values: standard keratometry and 14 computerized videokeratography values calculated using the axial, instantaneous, and refractive formulas. All calculations were performed with 1.3375 and 1.376 for the refractive index of the cornea. For each of the corneal values, we subtracted the change in corneal power from the change in manifest refraction and calculated for this difference the means, SDs, correlations, and regressions. RESULTS: Mean differences between change in refraction and change in corneal power were lower when for a refractive index of 1.376 than for 1.3375, were lowest for the most central measurement points, and displayed a high SD. A value of 1.408 for the refractive index would be required to optimize the correlation between change in manifest refraction and effective refractive power of the central 3 mm of the cornea. CONCLUSIONS: For individual patients who have undergone photorefractive keratectomy, changes in corneal values determined by computerized videokeratography or by standard keratometry do not reliably predict change in manifest refraction.

Adult↗

Diffuse lamellar keratitis associated with epithelial defects after laser in situ keratomileusis.

PURPOSE: To describe the association between the presence of epithelial defects and the development of diffuse lamellar keratitis (DLK), "Sands of the Sahara" syndrome, following laser in situ keratomileusis (LASIK). SETTING: Cullen Eye Institute, Department of Ophthalmology, Baylor College of Medicine, Houston, Texas, USA. METHODS: In this retrospective study, the postoperative clinical course and surgical outcomes in 735 eyes of 358 consecutive patients who had myopic LASIK between December 1998 and August 1999 were reviewed. Of the 735 procedures, 680 were primary LASIK procedures and 55 were retreatments performed by lifting the existing flaps. The incidence and severity of DLK and the relationship of DLK to epithelial defects were tabulated. RESULTS: Diffuse lamellar keratitis developed in 9 of the 16 eyes that had postoperative epithelial defects. Seventeen eyes without epithelial defects also developed DLK. The presence of an epithelial defect increased an individual's risk of developing DLK 24 times (95% confidence interval, 13 to 45). In 8 eyes, the inflammation resolved following treatment with intense topical corticosteroids. One eye had irrigation under the flap because of dense central inflammation; the final outcome was mild inferior corneal steepening. All eyes recovered preoperative best spectacle-corrected visual acuities. CONCLUSION: Patients who have epithelial defects of any size following LASIK are at significantly increased risk of developing DLK.

Adult↗

Optic neuropathy associated with laser in situ keratomileusis.

PURPOSE: To report 4 cases of optic neuropathy following laser in situ keratomileusis (LASIK). SETTING: Tertiary Care ophthalmic practices. METHODS: In this retrospective observational case series, 4 patients who developed acute visual loss following LASIK are reported. All had clinical evidence of optic neuropathy. Two had optic disc edema and 2 had normal appearing optic discs initially. None of the patients experienced significant visual recovery, and all developed optic atrophy in the affected eye. RESULTS: All patients had evaluations for alternative etiologies of their optic neuropathy, with negative results. All patients were therefore presumed to have experienced an ischemic optic neuropathy following LASIK. CONCLUSIONS: Patients who have LASIK may experience an acute anterior or retrobulbar optic neuropathy. The etiology is unknown but may be related to the marked increase in intraocular pressure that occurs during a portion of the procedure.

Adult↗

Comparative corneal topography and refractive variables in monozygotic and dizygotic twins.

PURPOSE: To investigate the role of heredity in determining corneal shape, axial length, and overall refractive error. METHODS: Twenty monozygotic and 19 dizygotic twin pairs, age 12 to 73 years, were enrolled in the study. Zygosity was determined by physical similarity and by responses to questions adapted from surveys. Two twin pairs were excluded because of undetermined zygosity and one pair because of keratoconus (both siblings). Refractive error was determined by an automated refractor. Manifest refraction was also recorded, as well as cycloplegic refraction in subjects under age 18 years. Corneal topography data and manual keratometer readings were also obtained. Axial lengths were determined by A-scan ultrasound. Data were analyzed by Student t tests only in the right eye. Left-eye data were comparable for all variables. RESULTS: Mean intrapair difference in refractive error (spherical equivalent) was less for monozygotic than for dizygotic twins (RE: 0.41 vs 1.53; P = .001). Mean intrapair difference in axial length was less for monozygotic twins (RE: 0.39 vs 0.76 mm; P = .031). Corneal topography data (power and meridian) in all zones (3, 5, and 7 mm) also showed smaller mean differences among monozygotic pairs than dizygotic, but the difference was statistically significant only for the 5-mm zone. In addition, most Holladay Diagnostic Summary variables that were studied did not show any statistically significant differences. CONCLUSIONS: Axial length and overall refractive error have a significant genetic basis. Corneal topography data appear to have other overriding determining factors for several of the variables studied.

Adolescent↗

Stability of vision during space flight in an astronaut with bilateral intraocular lenses.

PURPOSE: To report excellent and stable vision in an astronaut during space flight after bilateral cataract surgery with intraocular lenses. METHODS: A 60-year-old physician mission specialist astronaut developed cataracts and underwent phacoemulsification with insertion of one-piece polymethylmethacrylate intraocular lenses that had 6-mm optics bilaterally. Several months later, he flew on a space shuttle mission. Ocular examinations were performed before and after the mission, and the patient was questioned about visual changes during flight. RESULTS: Ocular examinations demonstrated stable bilateral posterior chamber intraocular lenses. Our subject reported excellent vision during liftoff, 18 days of microgravity, changes in cabin pressure, and reentry. CONCLUSION: Results suggest that intraocular lenses are safe, effective, and well tolerated during space flight.

Astronauts↗

Evaluation of relationships among refractive and topographic parameters.

PURPOSE: To examine the relationships among several refractive and topographic parameters. SETTING: Cullen Eye Institute Department of Ophthalmology, Baylor College of Medicine, Houston, Texas, USA. METHODS: Using computerized videokeratography (EyeSys Corneal Analysis System), 287 corneas of 150 patients were retrospectively analyzed. The Holladay Diagnostic Summary (HDS) refractive maps were used to evaluate relationships among variables of the HDS and refractive error. RESULTS: Myopic spherical equivalent refraction (P = .0003) and more negative asphericity (Q-values) (P = .0119) were correlated with steeper corneas. The Q-values were less negative in eyes with moderate myopia (2.0 to 6.0 diopters [D]) than in those with hyperopia (1.0 D or greater). The Q-values below -0.3 were correlated with less favorable values for predicted corneal acuity and corneal uniformity index values. Mean corneal curvature measurements obtained by computerized videokeratography and standard keratometry showed a strong degree of correlation (P = .0001). CONCLUSION: As the degree of myopia and negative asphericity increased, the corneal radius of curvature decreased. Corneal Q-values less than -0.3 were associated with reduced optical performance of the cornea.

Adolescent↗

Comparison of contact lens overrefraction and standard keratometry for measuring corneal curvature in eyes with lenticular opacity.

PURPOSE: To assess the accuracy of corneal power measurement by contact lens overrefraction in patients with normal corneas and to determine the suitability of this method for use in intraocular lens (IOL) calculations. SETTING: General ophthalmology clinic at a public hospital (Ben Taub General Hospital, Houston, Texas, USA). METHODS: Using contact lens overrefraction (CLO), and standard keratometry, the corneal power in 33 eyes of 20 normal patients and patients scheduled for cataract extraction was prospectively measured. The eyes were divided into 3 groups based on their best spectacle-corrected visual acuity: (1) 20/20 to 20/40, (2) 20/50 to 20/70, and (3) 20/80 to 20/400. For each group, the means (absolute and arithmetic), standard deviations, and ranges of differences in corneal power as measured by CLO and keratometry were calculated. These values were used to estimate the induced variance in refractive outcome for IOL calculations. RESULTS: The mean absolute differences in corneal power by group were 0.35 diopter (D) +/- 0.18 (SD), 0.54 +/- 0.33 D, and 0.77 +/- 0.28 D, respectively. The mean arithmetic differences in corneal power were -0.05 +/- 0.39 D, +0.37 +/- 0.51 D, and +0.17 +/- 0.80 D, respectively. CONCLUSIONS: In eyes of patients with good visual acuity (20/20 to 20/40), corneal power measurements by CLO and keratometry were similar. The accuracy of the CLO-derived value decreased with increasing media opacity but was still acceptable with acuity of 20/70. Contact lens overrefraction may be a viable alternative to refractive history and videokeratography for estimating true corneal power in patients with surgically altered or irregular corneas.

Cataract↗

Preoperative screening of contact lens wearers before refractive surgery.

PURPOSE: To evaluate corneal stability, measured by computerized videokeratography (CVK) after discontinuation of contact lens wear in preoperative refractive surgery candidates. SETTING: Baylor College of Medicine, Cullen Eye Institute, Houston, Texas, USA. METHODS: Topographic differences were analyzed in 136 noncontact lens wearers (NCLW) and 76 contact lens wearers (CLW) (18 rigid gas-permeable contact lenses [RGPCL], 58 soft contact lenses [SCL]) using EyeSys CVK after discontinuation of SCL wear for 2 weeks and RGPCL wear for 5 weeks. RESULTS: There were no differences in CVK patterns between the NCLW and the CLW groups. There were no statistically significant differences between the 2 groups in topographic symmetry, asphericity, corneal uniformity index, predicted corneal acuity, and irregular astigmatism. The dioptric range for the axial and the profile difference maps in the CLW group was slightly lower than in the NCLW group. CONCLUSIONS: For patients whose manifest refraction and CVK maps were within 0.5 diopters of earlier values, discontinuation of SCL wear for 2 weeks and RGPCL wear for 5 weeks was adequate for the cornea to return to its baseline topographic state.

Adult↗

Corneal topography classification in myopic eyes based on axial, instantaneous, refractive, and profile difference maps.

PURPOSE: To refine and develop systems for classifying the topography of myopic corneas using axial, instantaneous, refractive, and profile difference maps. SETTING: Baylor College of Medicine, Cullen Eye Institute Houston, Texas, USA. METHODS: Using the EyeSys Corneal Analysis System, computerized videokeratographs of 153 corneas of 78 myopic patients were retrospectively analyzed. Patterns were defined with respect to the mid-dioptric green color. Relationships among pattern types, refractive power, corneal power, corneal uniformity index (CU index), and predicted corneal visual acuity (PC acuity) were calculated. RESULTS: Six types of patterns for axial, instantaneous, and refractive maps and 3 types of patterns for the profile difference map were defined. For a given cornea, there was a weak correlation among the patterns in the axial, instantaneous, and profile difference maps. The circular with central irregularity pattern in auto-scale refractive maps and the irregular pattern in profile difference maps and axial maps were correlated with lower CU index and PC acuity values. Clinical classification of instantaneous maps did not contribute substantially to the information provided by axial maps. CONCLUSION: Patterns of computerized videokeratographs varied according to the type of topographic map. The classification systems used provide a baseline for analyzing the response of the cornea to various interventions.

Adult↗