LacriFill Canalicular Occlusion for Dry Eye After LASIK
Impact of LacriFill Lacrimal Occlusion on Post-LASIK Dry Eye Symptoms, Ocular Surface Recovery, and Patient-Reported Visual Quality
This study is a single-site, prospective, randomized (2:1) controlled study of subjects aged 18-39 who are candidates for bilateral LASIK and have dry eye symptoms (OSDI ≥13). The LacriFill group (n=50) receives bilateral lower canalicular LacriFill placement within 7 days prior to surgery plus standard postoperative care; the control group (n=25) receives standard postoperative care only. The primary outcome is the change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months after bilateral LASIK.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Melissa Hamann Wright, Study Staff
- 전화번호: 2389 713-580-2500
- 이메일: Melissa.Wright@manneye.com
연구 장소
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Texas
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Houston, Texas, 미국, 77004
- Mann Eye Institute
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연락하다:
- Melissa Hamann Wright
- 전화번호: 2389 713-580-2500
- 이메일: Melissa.Wright@manneye.com
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수석 연구원:
- Phillip Brunson, OD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Age 18-39 years. Bilateral LASIK candidate. OSDI ≥13. BCDVA 20/20 or better. Discontinue soft contact lenses within 5 days of surgery and RGP lenses 4 weeks prior.
Able to complete study visits.
Exclusion Criteria:
Previous ocular surgery. Keratoconus or ectasia. Autoimmune disease. Pregnancy. Uncontrolled diabetes. Significant ocular surface disease unrelated to LASIK. Active ocular infection or inflammation.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: LacriFill Group
Standard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50). |
LacriFill, a crosslinked hyaluronic acid-based bioresorbable gel, instilled for bilateral lower canalicular occlusion within 7 days prior to LASIK surgery. |
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간섭 없음: Control Group
Standard postoperative LASIK care only; no punctal plugs, LacriFill, or other canalicular occlusion before completion of the primary 3-month endpoint unless medically necessary as rescue therapy (n=25). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Ocular Surface Disease Index (OSDI) score
기간: 12 weeks
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The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. |
12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Ocular Surface Disease Index (OSDI) score
기간: 12 weeks
|
The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function. |
12 weeks
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Proportion of subjects achieving ≥10-point improvement in OSDI score
기간: 12 weeks
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Proportion of subjects achieving an improvement of 10 points or more in OSDI score from baseline following bilateral LASIK. |
12 weeks
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Proportion of subjects achieving OSDI score <13
기간: 12 weeks
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Proportion of subjects with an OSDI score below 13 (normal range) at the 12-week postoperative visit. |
12 weeks
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Change from baseline in tear break-up time (TBUT)
기간: 12 weeks
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12 weeks
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Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
기간: 12 weeks
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12 weeks
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Uncorrected distance visual acuity (UDVA)
기간: 12 weeks
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12 weeks
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Corrected distance visual acuity (CDVA)
기간: 12 weeks
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12 weeks
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Manifest refraction
기간: 12 weeks
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12 weeks
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Artificial tear usage and time to discontinuation of routine artificial tears
기간: 12 weeks
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Artificial tear usage, time to discontinuation of routine artificial tears, and requirement for rescue dry eye therapy through the 12-week postoperative visit. |
12 weeks
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Requirement for rescue dry eye therapy
기간: 12 weeks
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Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit. |
12 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PROWL-SS Questionnaire
기간: 12 weeks
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PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). |
12 weeks
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Change from baseline in iTrace Corneal Performance Index (CPI)
기간: 12 weeks
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Objective optical quality measure assessed at baseline and12-week postoperative visit. |
12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
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