Rebamipide Versus Diquafosol for Perioperative Dry Eye in Cataract Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorSamsung Medical Center

About this trial

This clinical trial is designed to compare two commonly used eye drop treatments for dry eye disease in patients undergoing cataract surgery.

Dry eye disease is common in people who need cataract surgery and may worsen before or after surgery, causing eye discomfort, blurred vision, and unstable vision. Proper management of dry eye before and after surgery may help improve eye comfort and the accuracy of vision outcomes.

In this study, patients with mild to moderate dry eye disease who are scheduled for cataract surgery will be randomly assigned to receive one of two treatments:

Rebamipide eye drops, or

Diquafosol eye drops

Participants will begin using the assigned eye drops one month before cataract surgery and continue treatment for three months after surgery. The eye drops will be used only in the eye undergoing surgery.

Researchers will examine whether one treatment is as effective as the other in improving tear film stability and reducing dry eye symptoms around the time of cataract surgery. Eye examinations and questionnaires will be performed before surgery, on the day of surgery, and during follow-up visits after surgery.

The information gained from this study may help doctors choose the most appropriate treatment for managing dry eye disease in patients undergoing cataract surgery.

Eligibility criteria

Qualifiers

Adults aged 40 years or older scheduled for unilateral cataract surgery

Tear film breakup time (TBUT) ≤7 seconds

Oxford corneal staining grade ≥1

Schirmer's test value ≤10 mm/5 minutes

Disqualifiers

Active ocular infection or inflammation, including infectious keratitis

History of ocular surgery other than cataract surgery in the study eye

Use of topical medications that may affect the ocular surface (e.g., intraocular pressure-lowering eye drops)

Any ocular or systemic condition judged by the investigator to interfere with study participation or outcome assessment

Trial design

Treatments tested in this trial

  • Rebamipide 2% ophthalmic solution
  • Diquafosol 3% ophthalmic solution

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators