Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes

Not Applicable

Completed

• Conditions: Epiretinal Membrane
• Interventions: Procedure: 25-G vitrectomy and phacoemulsification; Procedure: phacoemulsification (cataract surgery)

• Registration Number: NCT01771939
• Lead Sponsor: University of Turin, Italy

Brief Summary

The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.

Detailed Description

Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2006-11
• Study Completion: 2012-07
• Study First Submitted: 2012-12-13
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-16
• Last Update Submitted: 2013-01-16
• Study First Posted: 2013-01-18
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Idiopathic epiretinal membranes symptomatic

Exclusion Criteria

• Absence of ocular symptoms, previous retinal interventions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
idiopathic epiretinal membranes	25-G vitrectomy and phacoemulsification	Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention)
idiopathic epiretinal membrane	phacoemulsification (cataract surgery)	Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only

Primary Outcome Measures

Name	Time	Method
Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery	within 90,180,360,1360 days after surgery	We observed how did the visual acuity (using LogMar scale) increase after the two different surgical approaches described.

Secondary Outcome Measures

Name	Time	Method
Microperimetry parameters and average macular thickness changes	within 90,180,360,1360 days after surgery	We evaluated average sensitivity (SM) and local defect (DL) using microperimetry. We also evaluated the average macular thickness using optical coherence tomography technology.

Trial Locations

Locations (1)

Clinica Oculistica dell'Università, Ospedale Oftalmico; 🇮🇹 Turin, Italy