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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01771939

Enrollment

Registered

2013-01-18

Start date

2006-10-31

Completion date

2012-07-31

Last updated

2013-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane

Keywords

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

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.

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.

Interventions

PROCEDURE25-G vitrectomy and phacoemulsification

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

PROCEDUREphacoemulsification (cataract surgery)

lens extraction after phacoemulsification and intra-ocular artificial lens implantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 80 Years

Healthy volunteers

Inclusion criteria

* Idiopathic epiretinal membranes symptomatic

Exclusion criteria

* Absence of ocular symptoms, previous retinal interventions

Design outcomes

Primary

Measure	Time frame	Description
Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery	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

Measure	Time frame	Description
Microperimetry parameters and average macular thickness changes	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026