Topical Diclofenac on Macular Thickness After Phacoemulsification

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Topical Sodium Diclofenac on Macular Thickness in Diabetic Eyes After Phacoemulsification: A Randomized Controlled Trial

Conditions
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Diabetic Oculopathy

Intervention / Treatment
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* Drug: Prescribe ARTIFICIAL TEAR
* Drug: Prescribe diclofenac sodium drop 0.1%


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo (ARTIFICIAL TEAR)<br>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. | Drug: Prescribe ARTIFICIAL TEAR<br>* From one week before surgery, and 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<br>|
| Active Comparator: diclofenac sodium drop<br>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. | Drug: Prescribe diclofenac sodium drop 0.1%<br>* From one week before surgery, 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness changes | Optical coherence tomography (OCT) | preoperatively until 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity (BCVA) changes | LogMAR (Logarithm of the Minimum Angle of Resolution)charts | preoperatively until 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diclofenac, macular thickness, phacoemulsification, OCT(Optical coherence tomography ), diabetic