Effect of Dry Eye Treatment on Corneal Astigmatism Measurements
Effect of Dry Eye and Ocular Surface Treatment on Agreement and Repeatability of Corneal Astigmatism Measurements Among Three Devices
This prospective single-center study evaluates the effect of dry eye disease and short-term ocular surface treatment on the agreement and repeatability of corneal astigmatism measurements in patients with age-related cataract. Participants undergoing preoperative cataract evaluation are classified into a control group or a dry eye disease group according to ocular surface symptoms and objective tear film findings.
All participants undergo ocular surface assessment and repeated corneal measurements using three commonly used devices: IOLMaster 700, Pentacam AXL, and iTrace Prime. Measurements include keratometric corneal astigmatism, total corneal astigmatism, and vector components of astigmatism. Patients with dry eye disease receive 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, after which ocular surface assessment and device measurements are repeated.
The primary objective is to determine whether dry eye disease reduces interdevice agreement and test-retest repeatability of corneal astigmatism measurements, and whether short-term ocular surface treatment improves measurement stability. Interdevice agreement is assessed using Bland-Altman analysis, and repeatability is evaluated using within-subject standard deviation, test-retest repeatability, and intraclass correlation coefficient.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Baoxian Zhuo
- 이메일: 1532483480@qq.com
연구 연락처 백업
- 이름: Xuanqiao Lin, Doctor
- 전화번호: +8615088920668
- 이메일: 1532483480@qq.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200000
- 모병
- Eye and ENT hospital of Fudan University
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연락하다:
- Xuanqiao Lin
- 전화번호: 15088920668
- 이메일: 1532483480@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients with age-related cataract undergoing preoperative ocular examination.
- Ability to complete ocular surface evaluation, including the Ocular Surface
- Disease Index questionnaire, non-invasive tear film break-up time, tear meniscus height, Schirmer test, and ocular surface staining.
- Ability to complete repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
- Ability to maintain stable fixation during device measurements. Provision of written informed consent.
Exclusion Criteria:
- Previous ocular surgery or ocular trauma.
- Corneal degeneration, corneal dystrophy, or other corneal diseases that could affect corneal measurements.
- Active corneal or conjunctival infection.
- Uveitis.
- Use of any topical eye drops within 24 hours before examination.
- Use of antiglaucoma medications.
- Contact lens wear within 1 month before examination.
- Previous or ongoing treatment for dry eye disease.
- Poor fixation during device measurements.
- Poor-quality measurements from any study device
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control Cohort
Patients with age-related cataract who did not meet the diagnostic criteria for dry eye disease.
Participants underwent ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
No ocular surface treatment was administered in this cohort.
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실험적: Dry Eye Disease Cohort
Patients with age-related cataract who met the diagnostic criteria for dry eye disease.
Participants underwent baseline ocular surface evaluation and repeated corneal astigmatism measurements using IOLMaster 700, Pentacam AXL, and iTrace Prime.
They then received 0.3% sodium hyaluronate eye drops four times daily for 2 weeks, followed by repeat ocular surface evaluation and device measurements using the same protocol.
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0.3% sodium hyaluronate eye drops administered four times daily for 2 weeks in participants with dry eye disease.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Interdevice Agreement of Corneal Astigmatism Measurements
기간: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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Interdevice agreement of corneal astigmatism measurements among IOLMaster 700, Pentacam AXL, and iTrace Prime will be assessed using Bland-Altman analysis.
Pairwise comparisons will be performed for IOLMaster 700 versus Pentacam AXL, IOLMaster 700 versus iTrace Prime, and Pentacam AXL versus iTrace Prime.
The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45.
The mean difference and 95% limits of agreement will be calculated.
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Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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Test-Retest Repeatability of Corneal Astigmatism Measurements
기간: Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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Test-retest repeatability of corneal astigmatism measurements obtained using IOLMaster 700, Pentacam AXL, and iTrace Prime will be evaluated using three consecutive valid measurements from each device.
The main parameters include keratometric corneal astigmatism, total corneal astigmatism, and their vector components J0 and J45.
Repeatability will be assessed using within-subject standard deviation, test-retest repeatability calculated as 2.77 times the within-subject standard deviation, and intraclass correlation coefficient with 95% confidence intervals.
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Baseline and 2 weeks after ocular surface treatment in the dry eye disease arm.
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Xuanqiao Lin, Doctor, Fudan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- DryEye-2026-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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