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Results for “OPHTHALMOSCOPY”

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PubMed1989

Cotton-wool spots (inner retinal ischemic spots) in malignant arterial hypertension.

We produced experimental renovascular malignant arterial hypertension by modified Goldblatt's procedures, in 60 rhesus monkeys. Hypertensive retinopathy was studied in detail (by ophthalmoscopy, and stereoscopic color fundus photography and fluorescein fundus angiography on long-term follow-up). Cotton-wool spots (CWSs) were found to be an important, early retinal lesion. On ophthalmoscopy, they had a characteristic appearance. Fluorescein fundus angiography of these lesions revealed focal retinal capillary nonperfusion. The CWSs usually lasted for over 3 weeks and resolved within 6 weeks, leaving permanent obliteration of the retinal capillaries in their distribution, secondary intraretinal microvascular abnormalities, and retinal nerve fiber loss. We discuss pathogenesis and other features of CWSs. There is overwhelming evidence that CWSs are due to occlusion of the terminal retinal arterioles, resulting in acute focal inner retinal ischemia; hence the scientifically valid term for them would be 'inner retinal ischemic spots'.

Animals↗

PubMed2006

Fundus autofluorescence and mfERG for early detection of retinal alterations in patients using chloroquine/hydroxychloroquine.

PURPOSE: To evaluate and compare the value of fundus autofluorescence (FAF) imaging and multifocal electroretinography (mfERG) in early detection of retinal alterations in patients using chloroquine/hydroxychloroquine (CQ/HCQ). METHODS: FAF imaging was performed in a consecutive series of 25 patients with long-term CQ or HCQ treatment (duration, >1 year), with or without visual disturbances. In addition, mfERG was performed in accordance with ISCEV (International Society for Clinical Electrophysiology of Vision) guidelines in 23/25 patients. RESULTS: In 10/25 patients alterations of FAF were observed. Mild changes were limited to a pericentral ring of increased FAF. More advanced stages presented as pericentral mottled loss of FAF with increased FAF in the adjacent retina and later on a complete loss of pericentral FAF. In one case, a pericentral ring was observed when ophthalmoscopy and fluorescein angiography were normal. Marked progression of FAF abnormalities was observed during a 3-year follow-up in two of three patients. With the mfERG, pericentral, central, or generalized amplitude reductions were detected in all patients with FAF abnormalities and in an additional four patients with normal FAF. CONCLUSIONS: FAF imaging can be reliably used to detect early retinal pigment epithelial alterations in CQ/HCQ retinopathy. Ophthalmoscopy and fluorescein angiography appear to be less sensitive. With the mfERG, more retinal abnormalities were detected compared with FAF imaging.

Adult↗

PubMed1992

Usefulness of ophthalmic examination in postnatal observation in teratology studies.

Pregnant rats were irradiated with soft x-ray at a dose of 635 r or 1270 r on Day 9 or 11 of gestation. The eyes of F1 offspring were examined by indirect ophthalmoscopy and slit lamp biomicroscopy in postnatal weeks 3 to 7. Ophthalmoscopic examination of offspring irradiated at a dose of 635r or 1270r on Gestational Day 9 revealed iris and choroidal coloboma together with microphthalmia and anophthalmia at Postnatal Week 3 or later. Choroidal coloboma, an anomaly that cannot be detected by the common external observation method, was found ophthalmoscopically in one rat without any external ocular abnormalities. This fact suggests that ophthalmoscopy in postnatal observation can be useful to detect ocular teratogenic potential of test compounds in preclinical safety studies.

Abnormalities, Radiation-Induced↗

PubMed1993

Effects of soft X-ray irradiation on ocular development in Sprague-Dawley rats.

Pregnant rats were irradiated with soft x-rays at a dose of 1.6, 3.2, 6.3 or 12.6 Gy on Day 9 of gestation, and the eyes of F1 offspring were examined using indirect ophthalmoscopy and biomicroscopy during Postnatal Week 5. Ophthalmoscopic examination revealed iris and choroidal coloboma, microphthalmia and anophthalmia in the 3.2, 6.3 and 12.6 Gy groups. In addition to those anomalies, lens luxation and associated anterior displacement of the vitreous face, and retinal vascular anomalies were observed in the 12.6 Gy group. Histological examination revealed agenesis of retinal vessels. Ophthalmoscopic examination using biomicroscopy and indirect ophthalmoscopy detected choroidal coloboma, lens and vitreous luxation and defect in retinal vessels which could not be detected by external observation, demonstrating the usefulness of this technique in the postnatal stage of teratology studies.

Animals↗

PubMed2005

[The role of frequency doubling perimetry in the diagnosis of glaucoma: screening in employees of a public hospital in an urban area of São Paulo].

PURPOSE: To study the prevalence of glaucoma in employees of a public hospital in São Paulo and to analyze the role of frequency doubling perimetry along with non-contact tonometry and direct ophthalmoscopy, in the screening for glaucoma. METHODS: 612 employees of the Central Hospital of the "Santa Casa de São Paulo" were evaluated from October 15 to 20, 2000; 438 were women and 174 men, with mean age of 45.05+/-7.7 years (range, 35 to 81 years); 437 were white, 104 mulatto, 43 black and 28 Asian. All examinations were done by 10 eye specialists with experience in glaucoma. All employees had both eyes examined, by means of frequency doubling perimetry (FDT), ophthalmoscopy (FO), and non-contact tonometry (TNC). RESULTS: 159 (25.98%) subjects presented with at least one abnormal testing; 5 (3.14%) had high IOP (TNC+); 13 (8.17%) presented suspicious disk (FO+); 110 (69.18%) presented abnormal FDT (FDP+); 8 (5.03%) TNC+ and FO+; 10 (6.28%) had TNC+ and FDT+; 9 (5.66%) presented FO+ and FDT+; 4 (2.51%) had TNC+, FO+ and FDT+; 12 (1.96%) individuals were diagnosed with glaucoma, four of whom (0.65%), with normal pressure glaucoma. CONCLUSIONS: Frequency doubling perimetry was found to be an important step in the screening for glaucoma in the study. Of the 12 individuals that had the diagnosis of glaucoma, 5 (41.6%) would not have been diagnosed if they had not undergone frequency doubling perimetry.

Adult↗

PubMed2006

Proliferative diabetic retinopathy is associated with microalbuminuria in patients with type 2 diabetes.

Diabetic retinopathy is one of the leading causes of blindness in working-age individuals. Diabetic patients with proteinuria or those on dialysis usually present severe forms of diabetic retinopathy, but the association of diabetic retinopathy with early stages of diabetic nephropathy has not been entirely established. A cross-sectional study was conducted on 1214 type 2 diabetic patients to determine whether microalbuminuria is associated with proliferative diabetic retinopathy in these patients. Patients were evaluated by direct and indirect ophthalmoscopy and grouped according to the presence or absence of proliferative diabetic retinopathy. The agreement of diabetic retinopathy classification performed by ophthalmoscopy and by stereoscopic color fundus photographs was 95.1% (kappa = 0.735; P < 0.001). Demographic information, smoking history, anthropometric and blood pressure measurements, glycemic and lipid profile, and urinary albumin were evaluated. On multiple regression analysis, diabetic nephropathy (OR = 5.18, 95% CI = 2.91-9.22, P < 0.001), insulin use (OR = 2.52, 95% CI = 1.47-4.31, P = 0.001) and diabetes duration (OR = 1.04, 95% CI = 1.01-1.07, P = 0.011) were positively associated with proliferative diabetic retinopathy, and body mass index (OR = 0.90, 95% CI = 0.86-0.96, P < 0.001) was negatively associated with it. When patients with macroalbuminuria and on dialysis were excluded, microalbuminuria (OR = 3.3, 95% CI = 1.56-6.98, P = 0.002) remained associated with proliferative diabetic retinopathy. Therefore, type 2 diabetic patients with proliferative diabetic retinopathy more often presented renal involvement, including urinary albumin excretion within the microalbuminuria range. Therefore, all patients with proliferative diabetic retinopathy should undergo an evaluation of renal function including urinary albumin measurements.

Albuminuria↗

PubMed1991

Role of diabetologist in evaluating diabetic retinopathy.

OBJECTIVE: To evaluate the ability of diabetologists to screen diabetic patients for diabetic retinopathy. RESEARCH DESIGN AND METHODS: Comparison of eye examination performed by diabetologists with direct ophthalmoscopy through an undilated pupil and by ophthalmologists through a dilated pupil with seven-field stereoscopic fundus photography (gold standard). The study consisted of 67 insulin-dependent and non-insulin-dependent diabetic outpatients attending a diabetes clinic. RESULTS: On the basis of fundus photography, patients were classified as having no or insignificant (30%), minimal (31%), moderate (24%), or severe (15%) retinopathy. The diabetologists and ophthalmologists performed similarly in their ability to classify severity of diabetic retinopathy accurately. When no or insignificant retinopathy (isolated microaneurysms only) was detected by examination, clinically significant retinopathy detected by fundus photography was highly unlikely (less than 5%). On the other hand, if more than isolated microaneurysms were seen on examination, all examiners missed more severe lesions detected by fundus photography. Patients with corrected visual acuity worse than 20/30 had a high likelihood (100%) of moderate or severe retinopathy. CONCLUSIONS: Motivated well-trained diabetologists can screen for diabetic retinopathy. The absence of detectable lesions by direct ophthalmoscopy indicates that automatic referral to an ophthalmologist is not necessary. However, if any level of retinopathy is detected or corrected acuity is worse than 20/30, referral to an ophthalmologist is required. In this setting, fundus photography is advised because it is the most sensitive means of detecting clinically significant retinopathy. If other nonophthalmologists can be trained to achieve similar results, current recommendations for ophthalmologic referral that require annual ophthalmologic examinations for most diabetic patients may need to be reconsidered.

Adult↗

PubMed1993

Screening for diabetic retinopathy. The wide-angle retinal camera.

OBJECTIVE: To define the test characteristics of four methods of screening for diabetic retinopathy. RESEARCH DESIGN AND METHODS: Four screening methods (an exam by an ophthalmologist through dilated pupils using direct and indirect ophthalmoscopy, an exam by a physician's assistant through dilated pupils using direct ophthalmoscopy, a single 45 degrees retinal photograph without pharmacological dilation, and a set of three dilated 45 degrees retinal photographs) were compared with a reference standard of stereoscopic 30 degrees retinal photographs of seven standard fields read by a central reading center. Sensitivity, specificity, and positive and negative likelihood ratios were calculated after dichotomizing the retinopathy levels into none and mild nonproliferative versus moderate to severe nonproliferative and proliferative. Two sites were used. All patients with diabetes in a VA hospital outpatient clinic between June 1988 and May 1989 were asked to participate. Patients with diabetes identified from a laboratory list of elevated serum glucose values were recruited from a DOD medical center. RESULTS: The subjects (352) had complete exams excluding the exam by the physician's assistant that was added later. The sensitivities, specificities, and positive and negative likelihood ratios are as follows: ophthalmologist 0.33, 0.99, 72, 0.67; photographs without pharmacological dilation 0.61, 0.85, 4.1, 0.46; dilated photographs 0.81, 0.97, 24, 0.19; and physician's assistant 0.14, 0.99, 12, 0.87. CONCLUSIONS: Fundus photographs taken by the 45 degrees camera through pharmacologically dilated pupils and read by trained readers perform as well as ophthalmologists for detecting diabetic retinopathy. Physician extenders can effectively perform the photography with minimal training but would require more training to perform adequate eye exams. In this older population, many patients did not obtain adequate nonpharmacological dilation for use of the 45 degrees camera.

Diabetic Retinopathy↗

PubMed2003

Developing a screening program to detect sight-threatening diabetic retinopathy in South India.

OBJECTIVE: To develop a screening protocol for detection of sight-threatening diabetic retinopathy in south India. RESEARCH DESIGN AND METHODS: We performed ophthalmic examinations, including posterior segment examination, using indirect ophthalmoscopy to detect sight-threatening retinopathy in patients with diabetes in screening camps targeting a high-risk population. RESULTS: We examined 3,949 persons with diabetes in 32 screening camps over a 13-month period beginning July 2001. Most of the patients (93.6%) were aware of their diabetic status, and 84.2% of those aware of their diabetes status were on treatment. One-fifth of those screened had evidence for any retinopathy; only 6.1% of these persons had evidence of past ophthalmic treatment for retinopathy. Only one-quarter of those diagnosed with worse than mild retinopathy came for follow-up to the base hospital within 2 months. CONCLUSIONS: Screening high-risk groups for sight-threatening retinopathy using indirect ophthalmoscopy may be a useful short-term alternative for India until retinal photography becomes affordable. In addition to strategies to improve coverage, strategies for better follow-up of subjects screened also need to be evolved.

Adult↗

PubMed1997

The cost-effectiveness of various modes of screening for primary open angle glaucoma.

Various modes of screening for glaucoma were defined in terms of different combinations of the three main tests (ophthalmoscopy (O), tonometry (T), and perimetry (P)), together with associated referral criteria. The number of referrals and true positives generated by each mode was estimated for a model population, which was distributed with respect to age, intraocular pressure (IOP), optic disc condition, visual field defects, family history of glaucoma, and myopic status, as indicated by epidemiological studies. The costs of primary examination, and also of the secondary examination of referrals, were estimated for each mode, thus enabling the total cost per true positive to be calculated (in Pound sterling at 1995 UK prices, subsequently converted to US dollars at Pound 1.00 = $1.55.) The modes using O and T routinely, with P either routinely or selectively on all glaucoma high-risk groups, were found to provide the best balance between sensitivity (> or = 80%) and cost per true positive. The latter was around $850 when the cost of ophthalmoscopy could be shared as part of a general eye examination. The calculations assumed a 0.6% prevalence of previously undetected glaucomas in the community: with higher prevalences, costs per true positive would be lower. Screening the 40-59 years age group was found to be about as economic as for older people, when life expectancy was taken into account. It was concluded that glaucoma screening of people over age 40 years could be justifiable, provided that it is worth more than about $850 to detect a new case. Whilst based on UK values, the analysis could be applied to different primary health care settings in other countries.

Adolescent↗

PubMedDate not supplied

Fundus fluorescein angiography in the screening for and management of retinopathy of prematurity.

OBJECTIVES: To describe the characteristics of fundus fluorescein angiography in retinopathy of prematurity (ROP) and to explore the possible benefits of fundus fluorescein angiography over conventional indirect ophthalmoscopy in the screening for and management of ROP. PATIENTS AND METHODS: Beginning in January 2003, 23 consecutive patients were recruited for a nonrandomized, investigational trial. Fifty-one sessions of fundus fluorescein angiography were performed as part of ROP screening. RESULTS: Fundus fluorescein angiography caused no adverse effect. Clear angiograms were easily obtained. There was delayed arm-to-eye fluorescein transit. Leakage of fluorescein was observed in all stage 2 and stage 3 ROP. The leakage resolved soon after treatment. Arteriovenous tufts were found far posterior to the ROP ridge and were a feature of severe ROP. CONCLUSIONS: Some vascular pathology observed on angiograms cannot be seen on indirect ophthalmoscopy. There was delayed arm-to-eye transit and fluorescein transit within the eyes. Fundus fluorescein angiography allows more objective assessment of disease stage and zone. Regression of ROP is clearly observed on fundus fluorescein angiography.

Birth Weight↗

PubMedDate not supplied

Is there a role for high-frequency ultrasonography in clinical staging of retinopathy of prematurity?

PURPOSE: To compare 20-MHz ultrasonography with ophthalmoscopy in the staging of retinopathy of prematurity (ROP). METHODS: We used a handheld 20-MHz ultrasound system to examine 38 eyes of 19 neonates who had an indirect ophthalmoscopic examination (diagnosis masked) within 48 hours prior to ultrasonography. Determination of ROP by indirect ophthalmoscopy was compared with independent identification of ultrasonic features indicative of ROP stages. RESULTS: In masked cases, ultrasonography correctly identified 13 of 18 (72.2% sensitivity) eyes with zone 2, stage 2 ROP or worse and 19 of 20 (95.0% specificity) normal eyes (zone 2, stage 1 ROP or better) (chi-square, 18.4; P < .001). CONCLUSION: In the neonatal nursery, a 20-MHz handheld ultrasound system may be an effective screening tool to initially identify ROP for further ophthalmoscopic evaluation and management.

Anterior Eye Segment↗

PubMedDate not supplied

Optic nerve assessment: a clinical endpoint of optic neuropathy.

Objective, quantitative, and reproducible methods of optic nerve assessment need to be utilized during research that measures the capability of pharmacological agents to prevent or decrease the rate of progressive ganglion cell atrophy occurring with glaucoma. Confocal scanning laser ophthalmoscopy has recently been developed, and offers objective, quantitative, and three-dimensional evaluation of the optic nerve head and peripapillary retina. This article reviews the use, application, and parameters of one such instrument, the Heidelberg Retina Tomograph (HRT). Although HRT offers several methods to evaluate changes in optic nerve topography, these applications are still continually evolving. Therefore, confocal scanning laser ophthalmoscopy may be particularly useful for assessing the neuroprotective effect of new medications for glaucoma.

Glaucoma↗

PubMed1999

Comparison of the cost-effectiveness of three approaches to screening for and treating sight-threatening diabetic retinopathy.

The purpose of this study was to analyse and compare the costs involved in screening for and treating sight-threatening diabetic retinopathy in three different clinical settings. In the first setting, diabetologists screened using ophthalmoscopy and color photography, according to the St. Vincent Declaration guidelines, and selected patients for further assessment by a visiting ophthalmologist and for treatment in another hospital. In the second setting, all patients were regularly referred to ophthalmologists, either in the same hospital or elsewhere, for all aspects of eye care. In the third setting, screening was done again with ophthalmoscopy alone by diabetologists who followed the St. Vincent Declaration guidelines; however, further assessment and treatment were carried out in the eye department of the same hospital. Costs to the Italian National Health Service and to patients were calculated per screening performed and per patient subjected to laser treatment as a result of screening. A sensitivity analysis was then performed to simulate the costs of standardised patient populations going through the three different settings. It is concluded that absolute costs would be lower, both for the Italian National Health Service and for patients, if screening, assessment and treatment were all carried out in the same hospital. Equipping a diabetic clinic specially for screening would not be more expensive than delegating eye care to external parties, even for a hospital without an eye department. Moreover, delegating eye care more than doubles costs for patients. Screening for, assessing and treating sight-threatening diabetic retinopathy may be a cost-effective procedure for society as a whole in Italy.

Blindness↗

PubMed2000

The early detection of glaucoma in general practice.

BACKGROUND: Glaucoma is one of the most common preventable causes of visual loss. Because it is an asymptomatic condition until late in the process only 50% of the population with glaucoma are aware they have it. Primary care physicians rarely test their patients for glaucoma, primarily because of the lack of specificity or sensitivity of any one particular test. OBJECTIVE: To determine if it was possible to identify patients with early signs of glaucoma from within my own practice, in patients who had not previously been tested for glaucoma or had not been tested for at least two years. DISCUSSION: This study has shown that glaucoma case-finding is feasible in general practice. Direct ophthalmoscopy proved to be the most valuable single test in diagnosing glaucoma and the combination of measurement of intraocular pressure and direct ophthalmoscopy was shown to be the most likely method of diagnosing glaucoma or identifying glaucoma suspects.

Aged↗

PubMed2000

Dose dependency of canthaxanthin crystals in monkey retina and spatial distribution of its metabolites.

PURPOSE: To establish the threshold level of canthaxanthin crystals in the retina of cynomolgus monkeys. To correlate the spatial distribution of all-trans canthaxanthin and its metabolites with the grade of crystals. METHODS: Monkeys were orally administered 0, 0.2, 0.6, 1.8, 5.4, 16.2, and 48.6 mg/kg body wt canthaxanthin daily for 2.5 to 3 years. A second group of monkeys were administered 200 and 500 mg/kg body wt/d for 5 years. Ophthalmoscopy, electroretinography (ERG), retina and carotenoid analysis were performed as previously reported. RESULTS: Crystals in the retina periphery were observed by ophthalmoscopy preterminally only in the extreme high doses of 200 to 500 mg/kg body wt/d. There were no adverse effects on visual functions as measured by ERG. Crystals in the peripheral retina, and/or in the macula, were detected microscopically in all canthaxanthin treated groups except at the lowest dose of 0.2 mg/kg body wt/d. The grade of crystals increased up to a dose of 16.2 mg/kg body wt/d. Dose-dependent increases in canthaxanthin content also were noted in the retina, the liver, and in plasma. All-trans canthaxanthin was the major compound in the peripheral and paracentral retina of very highly dosed animals, where its concentration correlated largely with the grade of inclusions. In the macula, 4'-OH-echinenone was the dominant canthaxanthin metabolite. CONCLUSIONS: The grade of crystals in monkey retinas was dose dependent with a threshold level at 0.6 mg canthaxanthin/kg body wt/d. It correlated in the retinal periphery with the concentrations of all-trans-canthaxanthin and in the macula with its metabolites.

Administration, Oral↗

PubMed2000

Intravitreal toxicology and duration of efficacy of a novel antiviral lipid prodrug of ganciclovir in liposome formulation.

PURPOSE: To evaluate the intraocular safety and antiviral treatment efficacy of the sustained lipid prodrug of ganciclovir, 1-O-hexadecylpropanediol-3-phospho-ganciclovir (HDP-P-GCV), as an intravitreal injectable drug system for viral retinitis. METHODS: HDP-P-GCV was synthesized by coupling 1-O-hexadecyl-propanediol-3-phosphate to either free hydroxyl of ganciclovir in pyridine with dicyclohexylcarbodiimide as catalyst. The compound was formulated into liposomes. The antiviral activity was assessed by DNA reduction in vitro, and intraocular safety was assessed by ophthalmoscopy, electrophysiology, and histology after intravitreal injections, with resultant intravitreal concentrations of 0.2, 0.632, 1.12, and 2 mM. The treatment efficacy was evaluated by simultaneous intravitreal injection of HDP-P-GCV and herpes simplex virus type 1 (HSV-1) or by intravitreal injection of HDP-P-GCV at various times before HSV-1 intravitreal inoculation. Retinitis was scored with ophthalmoscopy and compared with controls. RESULTS: In vitro, the IC50 of HDP-P-GCV against HSV-1 and human cytomegalovirus (HCMV) infected cells was 0.02 and 0.6 microM, respectively. In rabbits in vivo, HDP-P-GCV dispersed evenly and maintained a good vitreous clarity at all doses except 2 mM final intravitreal concentration. Although cataracts were observed in some eyes at the higher doses, they were not observed in eyes with 0.2 mM final intravitreal concentration. No other indications of ocular toxicity were observed. Intravitreal injection of HDP-P-GCV with resultant 0.2 mM intravitreal concentration in the HSV-1 retinitis rabbit model demonstrated a complete protection of the retina with the simultaneous treatment strategy and a 4 (P = 0.03) to 6-(P = 0.058) week significant protection of retina with the pretreatment strategies when compared with ganciclovir or blank liposome controls. CONCLUSIONS: In the rabbit model of HSV-1 retinitis HDP-P-GCV acts as a long-lasting intravitreal injectable anti-CMV or anti-HSV compound. This self-assembling liposome system could be applicable for many compounds available for intraocular diseases.

Animals↗

PubMed2000

Interocular differences in optic disc topographic parameters in normal subjects.

PURPOSE: To test the interocular differences in optic disc topography in normal subjects by means of confocal scanning laser ophthalmoscopy. METHODS: Topographic measurements of the optic disc were evaluated by means of confocal scanning laser ophthalmoscopy (Heidelberg Retina Tomograph) in 314 eyes of 157 healthy volunteers. The examination was started randomly either with the right eye or the left eye. Differences between right and left eyes in disc area, cup area, cup volume, cup/disc area ratio, rim area, rim volume, maximum cup depth, cup shape measure, retinal nerve fiber layer thickness, and retinal nerve fiber cross section area for 360 degrees and for the temporal and nasal regions of the optic nerve head were evaluated by means of Student t-test. The same parameters were assessed in a subgroup of 80 elderly (age> 50 years) healthy subjects. Holm's sequentially rejective method was used for significance correction of multiple comparisons. RESULTS: Significant interocular differences in the average retinal nerve fiber layer thickness (p = 0.0010) and retinal nerve fiber layer cross section area (p = 0.0036) were found, with the right eye showing, on the average, lower values. The left eye showed a larger retinal nerve fiber layer thickness in 94 subjects (59.87%) and a larger retinal nerve fiber cross section area in 101 subjects (64. 33%). In the temporal optic disc area there were no statistically significant differences in topometric data (p> 0.05). In the nasal area, significant interocular differences in the retinal nerve fiber layer thickness (p = 0.0002) and retinal nerve fiber layer cross section area (p = 0.0003) were found. Similar results were found when the group of subjects older than 50 years was considered. CONCLUSIONS: This study demonstrates systematic interocular differences in optic disc topometric data. Such a finding, be it due to methodological or biological reasons, should be taken in consideration in clinical trials.

Adolescent↗