CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 target
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00347451
NCT00347451N/ACompleted

Optical Coherence Tomography Imaging of the Posterior Segment in High Myopia.

Singapore National Eye Centre·observational·Posted Jul 4, 2006·Updated May 12, 2010

In Brief

An observational study for Myopia and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The prevalence of myopia in East Asia and Singapore in particular is amongst the highest in the world, with estimates ranging from 30-70% of the general population. Up to 30% of these are high myopes. High myopia is associated with degenerative changes in the fundus. It may also be associated with vision-threatening complications such as macular holes. The pathogenesis of macular holes in high myopes is not completely understood but is postulated to include a combination of anterior vitreous traction and posterior staphyloma formation and axial elongation. These forces lead to degenerative changes at the macula, including foveal detachment and retinoschisis that precede the formation of lamellar or full thickness macular holes. These changes are difficult to detect either clinically or by conventional imaging such as ultrasound, making efforts to correct them in the early stages with surgery difficult. High myopia is also associated with a two- to threefold increase in risk of developing glaucoma. However, the diagnosis of glaucoma in high myopes is difficult as many of the pathological changes in the myopic eye mimic those seen in glaucoma. The myopic optic disc in particular is notoriously difficult to differentiate from the glaucomatous disc. Currently, the diagnosis is highly subjective, relying on observations of the clinical appearance of the disc or on disc photos.Optical coherence tomography (OCT) is an evolving technology that relies on time delays of reflected or backscattered light and interferometry to yield cross-sectional images of the retina and optic disc. The Stratus OCT is the latest model and has been demonstrated to be able to yield images with a resolution comparable to that of histology. It is thus potentially useful in assessing degenerative changes occurring in the myopic fundus, in evaluating the early changes preceding macular hole formation, and in providing objective measures of various disc parameters to aid in diagnosing glaucoma in high myopes. This study aims to recruit 150 healthy, young, ophthalmologically normal males from the SAF and to examine them with OCT. High myopes (≤-8D) will be selected and compared with a control group of low myopes. The performance of the OCT will be evaluated against current diagnostic methods.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSingapore
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2006
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 20.0 years ago