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

NCT ID: NCT01771939

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-07-31

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.

Conditions

Epiretinal Membrane

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

idiopathic epiretinal membranes

Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention)

Group Type: EXPERIMENTAL

25-G vitrectomy and phacoemulsification

Intervention Type: PROCEDURE

25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)

idiopathic epiretinal membrane

Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only

Group Type: ACTIVE_COMPARATOR

phacoemulsification (cataract surgery)

Intervention Type: PROCEDURE

lens extraction after phacoemulsification and intra-ocular artificial lens implantation

Interventions

25-G vitrectomy and phacoemulsification

25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)

Intervention Type: PROCEDURE

phacoemulsification (cataract surgery)

lens extraction after phacoemulsification and intra-ocular artificial lens implantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Idiopathic epiretinal membranes symptomatic

Exclusion Criteria

• Absence of ocular symptoms, previous retinal interventions

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Dal Vecchio

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Dal Vecchio, MD

Role: PRINCIPAL_INVESTIGATOR

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

Antonio M. Fea, MD, PhD

Role: STUDY_CHAIR

Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

Carlo A Lavia, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

Locations

Clinica Oculistica dell'Università, Ospedale Oftalmico

Turin, , Italy

Countries

Italy

Other Identifiers

VTCMER2

Identifier Type: -

Identifier Source: org_study_id