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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Melissa Hamann Wright, Study Staff
- Telefoonnummer: 2389 713-580-2500
- E-mail: Melissa.Wright@manneye.com
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77004
- Mann Eye Institute
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Contact:
- Melissa Hamann Wright
- Telefoonnummer: 2389 713-580-2500
- E-mail: Melissa.Wright@manneye.com
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Hoofdonderzoeker:
- Phillip Brunson, OD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: 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). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in Ocular Surface Disease Index (OSDI) score
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 12 weeks
|
12 weeks
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Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
Tijdsspanne: 12 weeks
|
12 weeks
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Uncorrected distance visual acuity (UDVA)
Tijdsspanne: 12 weeks
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12 weeks
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Corrected distance visual acuity (CDVA)
Tijdsspanne: 12 weeks
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12 weeks
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Manifest refraction
Tijdsspanne: 12 weeks
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12 weeks
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Artificial tear usage and time to discontinuation of routine artificial tears
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PROWL-SS Questionnaire
Tijdsspanne: 12 weeks
|
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)
Tijdsspanne: 12 weeks
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Objective optical quality measure assessed at baseline and12-week postoperative visit. |
12 weeks
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Phillip Brunson, OD, Mann Eye Institute
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PB-26-01
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