None listed
Conditions
Brief summary
BACKGROUND Myopia is defined as a refractive anomaly of the eye where parallel rays of light from an object at optical infinity are focused in front of the retina when accommodation is at rest. In recent years, the prevalence of myopia has increased dramatically especially in the East Asian population. In the year 2000, the prevalence of myopia was estimated to be 21% in 7 year olds, 61% in 12 year olds and a disturbingly high 81% in 15-year-old Taiwanese school children. While evaluating the causes of visual impairment and blindness in a group of adult Chinese in urban and rural region, it was found that 32.7% was contributed by degenerative myopia. However, the rapid and disturbing increase in the prevalence rates of high myopia over the years’ warrants amending our current knowledge on myopia. The distribution of peripheral refraction profile across different meridians and whether the pattern of distribution of the peripheral refraction can predict the progression of myopia needs to be investigated. The current study is planned to investigate up on a number of optic disc parameters to determine if there is an association between features such as tilt, torsion, RNFL thickness and choroidal thickness and progression of myopia. Analyzing this relationship will help in predicting myopia at an early stage. PURPOSE OF THE STUDY Correlating the peripheral refraction profile and structural variations in the optic disc in different meridians will guide us in identifying potential predictive factors responsible for the progression of myopia. The aim of this study is to determine if risk of progression of myopia can be identified using peripheral refractive error profile, optic disc features and retinal and choroidal thicknesses. STUDY DESIGN A cross sectional and interventional pilot study will be conducted as a first step to derive the required sample size and refine the experimental methods. The sample population aimed for this study is an age group between 18 to 39 years. The study sample will include a minimum of 20 participants to up to 50 participants in individual subgroups of emmetropia, hyperopia and myopia is planned for this pilot study. STUDY METHODS Preliminary examinations will be carried out in order to screen the individuals who fit into the eligibility criteria. The initial examinations included a routine ocular examination comprising detailed history taking, measurement of objective and subjective refraction values, anterior and posterior segment examination and measurement of intra ocular pressures. Participants who meet the inclusion criteria will undergo Shin Nippon auto-refractor and BHVI Eye-Mapper assessments for peripheral refraction profile at different field angles. The order of testing with these 2 instruments will be randomized using http://www.graphpad.com/quickcalcs/index.cfm online software. 3 repeat measurements will be obtained from both the instruments during the assessment by same examiner.
Interventions
Diagnostic instruments will be used to measure parameters like refractive status of the eye and posterior surface of the eye in detail (retina and optic nerve head), 3 repeat measurements will be obtained from the instruments used to analyze the peripheral refraction Brien Holden vision Institute (BHVI) eye mapper and Shin Nippon Auto Refractor. The order of testing with these 2 instruments will be randomized . This will be a single examiner study. Study location Brien Holden Clinical Research and Trial Centre Duration of this single visit study will be 60 to 90 minutes The entire study is planned to be completed within 6 to 9 months of the study period
Sponsors
Study design
Eligibility
Inclusion criteria
Healthy participants enrolled in the trial must be male or female aged between 18- 39 years, must have provided an informed consent, can be an emmetrope, hyperope or myopia , be willing to comply with clinical trial visit schedule as directed by the investigator, have ocular health findings considered to be “normal” and no anterior segment or posterior segment condition other than refractive error, have best corrected visual acuity to at least 6/9.5 or better in each eye with spectacles or contact lenses, have clear media for obtaining refractive error measurements and optic disc images
Exclusion criteria
Participants enrolled in the trial must not have astigmatism >/= 0.75 , should not be aged 40 years or older, should not have a history of any systemic diseases including diabetes, hypertension, cardiac problems etc, any refractive or ocular surgeries, using orthokeratology lenss, any other ocular pathology, ocular hypertension or glaucoma in either eye and intra ocular pressure >/= 21 mm of Hg