CompletedNot Applicable

Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye

Egypt55 participantsStarted 2019-06-01

Plain-language summary

Laser in situ keratomileusis (LASIK) eye surgery continues to be the most common refractive procedure used to correct different forms of ametropia. Although the introduction of femtosecond technology has markedly reduced the incidence of intraoperative flap complications and allowed a better control on flap parameters, dry eye remains one of the most challenging postoperative complications.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Candidates for Laser Vision Correction (LVC).
✓. Eyes with spherical equivalent (SE) up to - 10 diopters (D),
✓. Corneal thickness at thinnest location of ≥ 500 um and estimated postoperative residual stromal bed of at least 300 um

Exclusion criteria

✕. Patients with symptoms or signs of dry eye (TBUT \<10 sec, Schirmer I test \<10mm and Ocular Surface Disease Index OSDI score \>13),
✕. Posterior blepharitis, contact lens wearers ,
✕. Ocular surface disease ,
✕. Systemic diseases contraindicating LASIK and previous ocular surgery.

What they're measuring

Tear film break up time TBUT

Timeframe: 6 months

Schirmer I test

Timeframe: 6 months

Ocular Surface Disease Index OSDI

Timeframe: 6 months

Lower Tear meniscus height (LTMH)

Timeframe: 6 months

Lower Tear meniscus area (LTMA)

Timeframe: 6 months

Trial details

NCT IDNCT04831177

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-01

View on ClinicalTrials.gov More Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters trials