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

NCT01771939 | Completed DMC

• 1 other identifier: VTCMER2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane

Keywords

Idiopathic epiretinal membranes; 25-G surgery in idiopathic epiretinal membranes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microperimetry parameters and average macular thickness changes

  within 90,180,360,1360 days after surgery

Study Arms (2)

idiopathic epiretinal membranes

EXPERIMENTAL

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

Procedure: 25-G vitrectomy and phacoemulsification

idiopathic epiretinal membrane

ACTIVE COMPARATOR

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

Procedure: phacoemulsification (cataract surgery)

Interventions

25-G vitrectomy and phacoemulsification PROCEDURE

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

idiopathic epiretinal membranes

phacoemulsification (cataract surgery) PROCEDURE

lens extraction after phacoemulsification and intra-ocular artificial lens implantation

idiopathic epiretinal membrane

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic epiretinal membranes symptomatic

You may not qualify if:

• Absence of ocular symptoms, previous retinal interventions

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Clinica Oculistica dell'Università, Ospedale Oftalmico

Turin, 10100, Italy

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Vitrectomy; Phacoemulsification; Cataract Extraction

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Refractive Surgical Procedures; Ultrasonic Surgical Procedures

Study Officials

• Marco Dal Vecchio, MD

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

  PRINCIPAL INVESTIGATOR

• Antonio M. Fea, MD, PhD

  Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

  STUDY CHAIR

• Carlo A Lavia, MD

  Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: January 18, 2013
• Study Start: October 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: July 1, 2012
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

IT (1)