Diabetic retinopathy. Diabetic retinopathy
Conditions
Interventions
Intervention 1: Control group(PRP): PRP treatment by an argon green laser with a retinal spot size of 500 ?m and moderate intensity(until a hazy, mucoid and translucent choroidal lesion become eviden
Additional PRP at 3 and 6 months, if retreatment is needed
Macular Photocoagulation(MPC)at first visit or 3 and 6 months, if patients have clinically significant macular edema(CSME). Intervention 2: Treatment group(PRP plus IVB): PRP treatment by an argon gr
One intravitreal injection of 1.25 mg of Bevacizumab in one of the patients' eyes randomly, 120 min after completion of the first PRP session
Intravitreal injection of 1.25 mg of Bevacizumab, at 3 and 6 months, if retreatment is needed
Macular Photocoagulation(MPC)at first visit or 3 and 6 months, if patients have clinically significant macular edema(CSME).
Treatment - Other
Control group(PRP): PRP treatment by an argon green laser with a retinal spot size of 500 ?m and moderate intensity(until a hazy, mucoid and translucent choroidal lesion become evident), the duration
Treatment group(PRP plus IVB): PRP treatment by an argon green laser with a retinal spot size of 500 ?m and moderate intensity(until a hazy, mucoid and translucent choroidal lesion become evident), t
Sponsors
Tehran University Of Medical Sciences, Farabi Hospital, Ophthalmic Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Presence of severe Nonproliferative diabetic retinopathy or Proliferative diabetic retinopathy in both eyes; Normal intraocular pressure; Refractive error within ±3 diopter (D). Exclusion criteria: Any type of previous retinal treatment ( macular or peripheral laser photocoagulation, vitrectomy, intravitreal steroids and/or antiangiogenic drugs); Glaucoma or ocular hypertension; Significant media opacities that precluded fundus examination or imaging; Other retinal or optic nerve disease; Uncontrolled systemic hypertenion (BP = 180/110); Central macular thickness = 350
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular thickness. Timepoint: before intervention, 1, 3 and 6 months after intervention. Method of measurement: Spectral domain optical coherence tomograghy ( SD_OCT ).;Macular choroidal thickness. Timepoint: before intervention, 1, 3 and 6 months after intervention. Method of measurement: Spectral domain optical coherence tomograghy ( SD_OCT ).;Peripapillary nerve fiber layer thickness. Timepoint: before intervention, 1, 3 and 6 months after intervention. Method of measurement: Spectral domain optical coherence tomograghy ( SD_OCT ). | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity ( BCVA ). Timepoint: before intervention, 6 month after intervention. Method of measurement: Snellen acuity chart.;Total number of laser burns. Timepoint: after any PRP session. Method of measurement: by laser setting. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ramak Roohipoor
Farabi Hospital, Ophthalmic Research Center
Outcome results
None listed