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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epiretinal Membrane

Intervention / Treatment
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* Procedure: 25-G vitrectomy and phacoemulsification
* Procedure: phacoemulsification (cataract surgery)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic epiretinal membranes symptomatic Exclusion Criteria: Absence of ocular symptoms, previous retinal interventions

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: idiopathic epiretinal membranes<br>Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention) | Procedure: 25-G vitrectomy and phacoemulsification<br>* 25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)<br>|
| Active Comparator: idiopathic epiretinal membrane<br>Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only | Procedure: phacoemulsification (cataract surgery)<br>* lens extraction after phacoemulsification and intra-ocular artificial lens implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic epiretinal membranes, 25-G surgery in idiopathic epiretinal membranes