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

NCT00347451 | Completed

• 1 other identifier: R415/10/2005
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; Maculopathy; Glaucoma

Keywords

myopia; optical coherence tomography

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Myopic subjects

You may qualify if:

• Healthy young adult males with myopia \<-8D

You may not qualify if:

• Best corrected visual acuity \<6/9
• Previous intraocular surgery
• Intraocular pressure \>21mmHg
• Gonioscopic findings of angle closure
• Clinical evidence of pseudo-exfoliation, uveitis or pigment dispersion syndrome, corneal or media opacities, retinal pathology or neurological diseases
• Family history in a first degree relative of glaucoma or other optic neuropathy.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Related Publications (30)

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MeSH Terms

Conditions

Myopia; Macular Degeneration; Glaucoma

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Retinal Degeneration; Retinal Diseases; Ocular Hypertension

Study Officials

• Laurence S Lim, MBBS

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

• Tin Aung, PhD

  Singapore National Eye Centre

  STUDY DIRECTOR

• Bobby C Cheng, FRCS

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: October 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)