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

2010년 5월 11일 업데이트: Singapore National Eye Centre
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.

연구 개요

상태

완전한

상세 설명

Primary AimThe aim of the study is to evaluate the retinal and macular topography, vitreomacular relationships and optic nerve head changes in highly myopic eyes of young adults. Specific aims include:1) To determine the prevalence of vitreo-macular traction and macular degenerations (macular thickening, detachments, schisis or lamellar holes) in asymptomatic, highly myopic young Asian males using OCT.2) To characterize and measure optic nerve head and peripapillary retinal nerve fibre layer changes in high myopia using OCT.3) To compare OCT findings with current methods of investigation and diagnosis

SubjectsSubjects will be drawn from in-service personnel as well as recruits awaiting enlistment. They will be identified based on their refraction through the SAF's computerized medical records system.Informed consent will be sought from the subjects before commencement. All subjects will be healthy young males and will be ophthalmologically normal apart from myopia. The main exclusion criteria are:1) Best corrected visual acuity <6/92) Previous intraocular surgery3) Intraocular pressure >21mmHg4) Gonioscopic findings of angle closure5) Clinical evidence of pseudo-exfoliation, uveitis or pigment dispersion syndrome, corneal or media opacities, retinal pathology or neurological diseases6) Family history in a first degree relative of glaucoma or other optic neuropathy.Excluded subjects will be replaced by the subject next-in-line in the cohort.ProcedureAll subjects identified will be examined at SNEC/SERI by one of the investigators. The assessment for each subject will include:1) Autorefraction performed with a non-accommodating target and recording of best corrected visual acuity. 2) Slit lamp examination, Goldmann applanation tonometry, gonioscopy, examination with a Goldmann three-mirror lens, and a dilated fundus examination with a 78 diopter fundus lens. Retinal findings are recorded in standard Amsler Dubois retinal diagrams. Grading of background myopic chorioretinal changes will be in accordance with the scheme proposed by Avila . 3) Axial length measurements. Ultrasound A scan is performed for each eye. Axial length is ascertained from the average of six consistent recordings. Care is taken to locate the fovea especially in cases with posterior staphyloma, by ensuring fixation of the A scan probe light. 4) Fundus photography with the Topcon camera. Stereoscopic disc photographs will also be taken for comparison with OCT scans of the optic nerve head.5) OCT using the Stratus OCTOCT measurements will be performed at one sitting by a trained technician. The commercially prescribed Optic Disc, RNFL and Macular Thickness scanning algorithms will be used. Each subject will fixate on an internal target presented by the computer where possible, or an external fixation target for cases unable to cooperate. Subjects will be encouraged to blink between the acquisition of each radial scan to minimize discomfort and minimize the effect of an irregular tear film or corneal desiccation on the tear film. Each scan will take approximately 2.5s, making for a total image acquisition time of less than a minute. The optic nerve head scan consists of six radial scans centered on the optic nerve head. The computer generated disc margin will be used as the reference for optic nerve head measurements. The macular thickness protocol uses six radial scans centered on the fovea. The retinal thickness is measured automatically as the distance between the vitreoretinal interface and the junction between the inner and outer segments of photoreceptors.

연구 유형

관찰

등록 (예상)

150

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Singapore, 싱가포르, 168751
        • Singapore National Eye Centre

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Myopic subjects

설명

Inclusion Criteria:

  • Healthy young adult males with myopia <-8D

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Laurence S Lim, MBBS, Singapore National Eye Centre
  • 연구 책임자: Tin Aung, PhD, Singapore National Eye Centre
  • 수석 연구원: Bobby C Cheng, FRCS, Singapore National Eye Centre

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2005년 10월 1일

기본 완료 (실제)

2006년 6월 1일

연구 완료 (실제)

2006년 6월 1일

연구 등록 날짜

최초 제출

2006년 6월 30일

QC 기준을 충족하는 최초 제출

2006년 6월 30일

처음 게시됨 (추정)

2006년 7월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2010년 5월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2010년 5월 11일

마지막으로 확인됨

2010년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • R415/10/2005

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