Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD

Retinal Detachment Clinical Trial

Official title:

Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139811
• Other study ID #: 66-7/2018
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: October 2019
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.

The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.

In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.

Description:

interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 73 Years

Eligibility

Inclusion Criteria:

• All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).

Exclusion Criteria:

• Complicated cases with advanced proliferative vitreoretinopathy (PVR).

• Patients with retinal vascular disorders and other macular disorders.

• Combined tractional and rhegmatogenous detachment.

• Previous retinal reattachment surgery or Intravitreal injections.

• Glaucomatous patients.

• Patients with corneal opacity which impairs good visualization.

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Other:
• Pars Plana Vitrectomy
vitrectomy with and without ILM peeling

Locations

Country	Name	City	State
Egypt	Minia UNiversity hospital	Minya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anatomical outcome	Rate of retinal reattachment using indirect ophthalmoscopy	6 months follow up
Primary	epiretinal membrane	incidence rate of epiretinal membrane formation after surgery in % percent	6 months follow up
Secondary	functional outcome	visual functions using log Mar Best Corrected Visual Acuity (BCVA)	6 months follow up
Secondary	superficial capillary density	measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography	6 months follow up
Secondary	multi-focal Electroretinogram	measurement of P1 amplitude	6 months follow up