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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Melissa Hamann Wright, Study Staff
- Telefonnummer: 2389 713-580-2500
- E-mail: Melissa.Wright@manneye.com
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77004
- Mann Eye Institute
-
Kontakt:
- Melissa Hamann Wright
- Telefonnummer: 2389 713-580-2500
- E-mail: Melissa.Wright@manneye.com
-
Ledende efterforsker:
- Phillip Brunson, OD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Ingen indgriben: 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Ocular Surface Disease Index (OSDI) score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Uncorrected distance visual acuity (UDVA)
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Corrected distance visual acuity (CDVA)
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Manifest refraction
Tidsramme: 12 weeks
|
12 weeks
|
|
|
Artificial tear usage and time to discontinuation of routine artificial tears
Tidsramme: 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
Tidsramme: 12 weeks
|
Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit. |
12 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PROWL-SS Questionnaire
Tidsramme: 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)
Tidsramme: 12 weeks
|
Objective optical quality measure assessed at baseline and12-week postoperative visit. |
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Phillip Brunson, OD, Mann Eye Institute
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PB-26-01
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