Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Egypt
Ain Shams university
ACTIVE_NOT_RECRUITING
Cairo
Ain Shams university
RECRUITING
Cairo
Contact Information
Primary
Azza MA Said, MD
dr_azza_22@hotmail.com
2001006228992
Backup
David G Samuel, Mscc
david.samuel.ophth@gmail.com
2001064442469
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 20
Treatments
Active_comparator: subjecting to vitrectomy + ILM peeling only
Active_comparator: subjecting to vitrectomy + ILM peeling + planned foveal detachment
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University