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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271473
• Other study ID #: AinShamsU3
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Azza MA Said, MD
• Phone: 2001006228992
• Email: dr_azza_22[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• Macular Edema
• Safety

Intervention

Procedure:
• vitrectomy + 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.

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	any surgical complication or recurrence of DME		after 1 month and 3 months
Primary	change in CMT by OCT at final visit	decrease or increase in central macular thickness by OCT	after 1 month and 3 months
Secondary	change in BCVA at final visit	decrease or increase in best corrected visual acuity	after 1 month and 3 months