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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Melissa Hamann Wright, Study Staff
- Telefonnummer: 2389 713-580-2500
- E-post: Melissa.Wright@manneye.com
Studieorter
-
-
Texas
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Houston, Texas, Förenta staterna, 77004
- Mann Eye Institute
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Kontakt:
- Melissa Hamann Wright
- Telefonnummer: 2389 713-580-2500
- E-post: Melissa.Wright@manneye.com
-
Huvudutredare:
- Phillip Brunson, OD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: 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). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
Tidsram: 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
|
|
Proportion of subjects achieving ≥10-point improvement in OSDI score
Tidsram: 12 weeks
|
Proportion of subjects achieving an improvement of 10 points or more in OSDI score from baseline following bilateral LASIK. |
12 weeks
|
|
Proportion of subjects achieving OSDI score <13
Tidsram: 12 weeks
|
Proportion of subjects with an OSDI score below 13 (normal range) at the 12-week postoperative visit. |
12 weeks
|
|
Change from baseline in tear break-up time (TBUT)
Tidsram: 12 weeks
|
12 weeks
|
|
|
Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
Tidsram: 12 weeks
|
12 weeks
|
|
|
Uncorrected distance visual acuity (UDVA)
Tidsram: 12 weeks
|
12 weeks
|
|
|
Corrected distance visual acuity (CDVA)
Tidsram: 12 weeks
|
12 weeks
|
|
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Manifest refraction
Tidsram: 12 weeks
|
12 weeks
|
|
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Artificial tear usage and time to discontinuation of routine artificial tears
Tidsram: 12 weeks
|
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
|
|
Requirement for rescue dry eye therapy
Tidsram: 12 weeks
|
Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit. |
12 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PROWL-SS Questionnaire
Tidsram: 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
|
|
Change from baseline in iTrace Corneal Performance Index (CPI)
Tidsram: 12 weeks
|
Objective optical quality measure assessed at baseline and12-week postoperative visit. |
12 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Phillip Brunson, OD, Mann Eye Institute
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PB-26-01
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