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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04139811

Enrollment

Registered

2019-10-25

Start date

2017-03-15

Completion date

2019-08-15

Last updated

2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

Internal limiting membrane, multifocal electoretinogram (ERG), OCT-Angiography

Brief 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.

Detailed description

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

Interventions

OTHERPars Plana Vitrectomy

vitrectomy with and without ILM peeling

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 73 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
anatomical outcome	6 months follow up	Rate of retinal reattachment using indirect ophthalmoscopy
epiretinal membrane	6 months follow up	incidence rate of epiretinal membrane formation after surgery in % percent

Secondary

Measure	Time frame	Description
functional outcome	6 months follow up	visual functions using log Mar Best Corrected Visual Acuity (BCVA)
superficial capillary density	6 months follow up	measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography
multi-focal Electroretinogram	6 months follow up	measurement of P1 amplitude

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026