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

Morphologic and Functional Results After Phacoemulsification and 25 Gauge Vitrectomy Versus Phacoemulsification Only in Eyes Affected by Idiopathic Epiretinal Membranes

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.

Study Overview

• Status: Completed
• Conditions: Epiretinal Membrane
• Intervention / Treatment: Procedure: 25-G vitrectomy and phacoemulsification; Procedure: phacoemulsification (cataract surgery)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10100
    • Clinica Oculistica dell'Università, Ospedale Oftalmico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Idiopathic epiretinal membranes symptomatic

Exclusion Criteria:

• Absence of ocular symptoms, previous retinal interventions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: idiopathic epiretinal membranes; Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention)	Procedure: 25-G vitrectomy and phacoemulsification; 25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)
Active Comparator: idiopathic epiretinal membrane; Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only	Procedure: phacoemulsification (cataract surgery); lens extraction after phacoemulsification and intra-ocular artificial lens implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Investigators: Principal Investigator: Marco Dal Vecchio, MD, Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy 10100; Study Chair: Antonio M. Fea, MD, PhD, Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy; Principal Investigator: Carlo A Lavia, MD, Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Idiopathic epiretinal membranes; 25-G surgery in idiopathic epiretinal membranes
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Epiretinal Membrane
• Other Study ID Numbers: VTCMER2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No