Efficacy, Safety
Conditions
Keywords
refractory diabetic macular edema, internal limiting membrane peeling, pars plana vitrectomy, subretinal injection of ringer lactate
Brief summary
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
Detailed description
In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME. To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
Interventions
PROCEDUREvitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
20 eyes of 20 patients will be divided randomly into 2 groups: * Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only * Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age: above 40 years old. * Patients with type two diabetes mellitus of more than 5 years duration. * Patients with Best corrected visual acuity better than 3/60. * Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit. * No evidence of vitreomacular traction. * Lens status: Pseudophakia or clear crystalline lens.
Exclusion criteria
Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological). * Ischemic maculopathy by FFA. * Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally. * Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula. * Presence of proliferative diabetic fibrovascular membranes threatening or at the macula. * Presence of diabetic optic atrophy or neuropathy. * Presence of neovascular glaucoma. * Cataractous lens either preoperatively or as intra or postoperative complication. * Vitrectomized Eyes. * A prior intraocular surgery within the past six-months. * Lost follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in CMT by OCT at final visit | after 1 month and 3 months | decrease or increase in central macular thickness by OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in BCVA at final visit | after 1 month and 3 months | decrease or increase in best corrected visual acuity |
Other
| Measure | Time frame |
|---|---|
| any surgical complication or recurrence of DME | after 1 month and 3 months |
Countries
Egypt
Contacts
Primary ContactAzza MA Said, MD
Backup ContactDavid G Samuel, Mscc
Outcome results
None listed