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

Epiretinal Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771939
• Other study ID #: VTCMER2
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: January 16, 2013
• Start date: October 2006
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Idiopathic epiretinal membranes symptomatic

Exclusion Criteria:

• Absence of ocular symptoms, previous retinal interventions

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Procedure:
• 25-G vitrectomy and phacoemulsification
25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)
• phacoemulsification (cataract surgery)
lens extraction after phacoemulsification and intra-ocular artificial lens implantation

Locations

Country	Name	City	State
Italy	Clinica Oculistica dell'Università, Ospedale Oftalmico	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No