Diabetic Oculopathy
Conditions
Keywords
diclofenac, macular thickness, phacoemulsification, OCT(Optical coherence tomography ), diabetic
Brief summary
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.
Interventions
DRUGPrescribe ARTIFICIAL TEAR
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
DRUGPrescribe diclofenac sodium drop 0.1%
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
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| macular thickness changes | preoperatively until 90 days | Optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| best corrected visual acuity (BCVA) changes | preoperatively until 90 days | LogMAR (Logarithm of the Minimum Angle of Resolution)charts |
Countries
Iran
Outcome results
None listed