Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME

Not Applicable

Recruiting

• Conditions: Efficacy; Safety
• Interventions: Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.

• Registration Number: NCT06271473
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2024-02
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subjecting to vitrectomy + ILM peeling only	vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.	-
subjecting to vitrectomy + ILM peeling + planned foveal detachment	vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.	-

Primary Outcome Measures

Name	Time	Method
change in CMT by OCT at final visit	after 1 month and 3 months	decrease or increase in central macular thickness by OCT

Secondary Outcome Measures

Name	Time	Method
change in BCVA at final visit	after 1 month and 3 months	decrease or increase in best corrected visual acuity

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt