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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Dal Vecchio, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01771939
First received: December 13, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Epiretinal Membrane
Procedure: 25-G vitrectomy and phacoemulsification
Procedure: phacoemulsification (cataract surgery)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morphologic and Functional Results After Phacoemulsification and 25 Gauge Vitrectomy Versus Phacoemulsification Only in Eyes Affected by Idiopathic Epiretinal Membranes

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery [ Time Frame: within 90,180,360,1360 days after surgery ] [ Designated as safety issue: No ]
    We observed how did the visual acuity (using LogMar scale) increase after the two different surgical approaches described.


Secondary Outcome Measures:
  • Microperimetry parameters and average macular thickness changes [ Time Frame: within 90,180,360,1360 days after surgery ] [ Designated as safety issue: No ]
    We evaluated average sensitivity (SM) and local defect (DL) using microperimetry. We also evaluated the average macular thickness using optical coherence tomography technology.


Enrollment: 60
Study Start Date: October 2006
Study Completion Date: July 2012
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic epiretinal membranes symptomatic

Exclusion Criteria:

  • Absence of ocular symptoms, previous retinal interventions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771939

Locations
Italy
Clinica Oculistica dell'Università, Ospedale Oftalmico
Turin, Italy, 10100
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Marco Dal Vecchio, MD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01771939     History of Changes
Other Study ID Numbers: VTCMER2
Study First Received: December 13, 2012
Last Updated: January 16, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Turin, Italy:
Idiopathic epiretinal membranes
25-G surgery in idiopathic epiretinal membranes

Additional relevant MeSH terms:
Epiretinal Membrane
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 27, 2014