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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rebamipide 2% ophthalmic solution
DrugTopical administration to the surgical eye, four times daily.
Diquafosol 3% ophthalmic solution
DrugTopical administration to the surgical eye, four times daily.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Rebamipide GroupExperimental treatment 1 intervention
Group B: Diquafosol GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Tear Film Breakup Time (TBUT)
Change in tear film breakup time (TBUT) from baseline to the postoperative period, comparing rebamipide and diquafosol for perioperative management of dry eye disease in patients undergoing cataract surgery.
Time frame
From baseline to postoperative 1 monthSecondary outcomes
1
Change in Ocular Surface Disease Index (OSDI) Score
Change in patient-reported dry eye symptoms assessed using the Ocular Surface Disease Index (OSDI) questionnaire.
Time frame
From baseline to postoperative 1 and 3 months2
Change in Corneal Staining Grade (Oxford Scale)
Change in corneal epithelial staining graded using the Oxford scale following fluorescein staining.
Time frame
From baseline to postoperative 1 month3
Change in Schirmer's Test Value
Change in tear secretion measured by Schirmer's test without anesthesia.
Time frame
From baseline to postoperative 1 and 3 months4
Change in Tear Matrix Metalloproteinase-9 (MMP-9) Level
Change in tear matrix metalloproteinase-9 (MMP-9) levels assessed using a commercially available tear MMP-9 test.
Time frame
From baseline to postoperative 1 and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: