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OpenTrials
Completed

NCT Number: NCT01771939

Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in 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.

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Key information

Conditions

Epiretinal Membrane Eye Diseases Retinal Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Oculistica dell'Università, Ospedale Oftalmico

Turin, 10100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic epiretinal membranes symptomatic

Exclusion criteria

  • Absence of ocular symptoms, previous retinal interventions

Treatment and study plan

25-G vitrectomy and phacoemulsification

Procedure

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

phacoemulsification (cataract surgery)

Procedure

lens extraction after phacoemulsification and intra-ocular artificial lens implantation

Primary outcomes

  1. Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery

    Time frame: within 90,180,360,1360 days after surgery

    We observed how did the visual acuity (using LogMar scale) increase after the two different surgical approaches described.

Secondary outcomes

  1. Microperimetry parameters and average macular thickness changes

    Time frame: within 90,180,360,1360 days after surgery

    We evaluated average sensitivity (SM) and local defect (DL) using microperimetry. We also evaluated the average macular thickness using optical coherence tomography technology.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2012
First posted
Jan 18, 2013
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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