Topical Diclofenac on Macular Thickness After Phacoemulsification (diclofenac)

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Diabetic Oculopathy

Treatments: Drug: Prescribe diclofenac sodium drop 0.1%; Drug: Prescribe ARTIFICIAL TEAR

Study type: Interventional

Funder types: Other

Identifiers

NCT02306031

88108

Details and patient eligibility

About

Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.

Enrollment: 108 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diabetic patients with non-proliferative diabetic retinopathy that were candidate for phacoemulsification and intraocular lens implantation

Exclusion criteria

• Eyes with clinically significant macular edema based on the ETDRS(Early Treatment Diabetic Retinopathy Study) study and/or central macular thickness >260µ were not included. Neither did we include the eyes with other accompanying diseases affecting the macula or eyes with history of previous retinal laser photocoagulation or intraocular surgery.
• Eyes with severe cataract that preclude performing an acceptable quality optical coherence tomography (OCT) were not enrolled either.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

placebo (ARTIFICIAL TEAR)

Placebo Comparator group

Description:

control group received artificial tear (Sina Darou Laboratories Company, Tehran, Iran) as a placebo every 6 hours. Theses drops continued up to 6 weeks with the same dose after operations.

Treatment:

Drug: Prescribe ARTIFICIAL TEAR

diclofenac sodium drop

Active Comparator group

Description:

case group received diclofenac sodium drop 0.1% (Sina Darou Laboratories Company, Tehran, Iran) every 6 hours.. Theses drops continued up to 6 weeks with the same dose after operations.

Treatment:

Drug: Prescribe diclofenac sodium drop 0.1%