- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05209204
Anterior Chamber Angle Examination in Angle Closure Suspect Patients
연구 개요
상세 설명
Glaucoma is a form of progressive optic neuropathy and is one of the leading causes of preventable blindness worldwide. The average life span is increasing leading to more individuals developing glaucoma as well as having the disease longer, which makes early detection and management very important.[1] Glaucoma is characterized by loss of retinal ganglion cells (RGCs) recognized as optic nerve head (ONH) changes, corresponding visual field (VF) defects and retinal nerve fiber layer (RNFL) loss. At least 40% of RGCs are lost before the VFs show a defect, hence the emphasis on early diagnosis in the stage of glaucoma suspect.[2] There are two types of glaucoma suspect: Primary Open angle and primary angle closure suspect.(3) Primary angle-closure (PAC) suspects can be detected by the following: the trabecular meshwork can only be seen in 180º or less of anterior chamber angle (AC) by gonioscopy, the intraocular pressure(IOP) remains within normal limits and no structural damage to the optic nerve is present.[4] Time domain Optical coherence tomography (TD-OCT) was initially designed to image the posterior segment and retina, but its capability to generate cross-sectional images of internal biological structures without contacting the ocular surface was quickly adapted to visualize the anterior segment and cornea.[5].
Spectral domain anterior segment OCT (SD-OCT) technology allow visualizing the anterior chamber angle of the eye with high speed and high resolution. Spectral-domain OCT(SD OCT) instruments working at 840 nm can reliably identify fine angle structures such as Schwalbe's line.(6) Scheimpflug imaging also offers non-contact imaging of the anterior segment. Although Scheimpflug photography cannot fully visualize the entire angle, the software available on the Pentacam system (Oculus Optikgeräte, Wetzlar, Germany) provides extrapolated measurements of the anterior chamber volume (ACV), which have shown promise in screening for narrow angles.(7)
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
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Minya, 이집트
- Minia University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Hyperopes. 2-Shallow AC. 3-With gonioscopy carried out under dim-light conditions without indentation ,with the eye in primary position there is inability to visualize ≤ 180° of the posterior trabecular meshwork (TM) in the absence of peripheral anterior 4-IOP ≤ 21 as measured by tonometry. 5-Normal visual field on static automated perimetry (SAP) testing. 5-Normal optic nerve head (ONH) appearance on fundus biomicroscopy. 6-Family history of primary angle closure disease.
Exclusion Criteria:
1-Eyes with significant corneal opacity that can impare signal strings of any of the used imaging modalities.
2-Eyes wih history of intraocular surgery (e.g. cataract surgery ,retinal detachment surgery).
3-Eyes with history of laser procedures (e.g.laser peripheral iridotomy). 4-Eyes with anterior segment pathology as iridocyclitis or angle disgenesis 5. Eyes with history of trauma. 6- Eyes with findings suggestive of 2dry cause of glaucoma (e.g. iris or angle neovascularization, any iris or corneal abnormalities, dilated episcleral vessels ).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
40 pateint glucoma suspect
ASOCT
|
Anterior segment imaging using RTVue XR 100 Avanti OCT platform (Optovue Inc.,Fairmont, CA).
Anterior segment imaging using Oculus Pentacam HR (Oculus Optikgeräte, Wetzlar, Germany).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Anterior segment parameters as measured by AS-OCT:
기간: 3 months
|
Anterior chamber depth (ACD)..
|
3 months
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Anterior segment parameters as measured by Oculus Pentacam:
기간: 3 months
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Anterior chamber angle (ACA).
|
3 months
|
Anterior segment parameters by ASOCT
기간: 3 months
|
Angle opening distance at 750 µm (AOD750).
|
3 months
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Anterior segment parameters by OCT
기간: 3 months
|
Anterior chamber angle (ACA).
|
3 months
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Pentacam parameters
기간: 3 months
|
Anterior chamber volume (ACV).
|
3 months
|
Pentacam parameters by Oculus Pentacam:
기간: 3 months
|
Anterior chamber depth (ACD).
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3 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mohamed Salah, Minia University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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