Back to results

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

Primary Purpose

Epiretinal Membrane

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

25-G vitrectomy and phacoemulsification

phacoemulsification (cataract surgery)

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring Idiopathic epiretinal membranes, 25-G surgery in idiopathic epiretinal membranes

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Idiopathic epiretinal membranes symptomatic

Exclusion Criteria:

Absence of ocular symptoms, previous retinal interventions

Sites / Locations

Clinica Oculistica dell'Università, Ospedale Oftalmico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

idiopathic epiretinal membranes

idiopathic epiretinal membrane

Arm Description

Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention)

Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01771939

First Posted

December 13, 2012

Last Updated

January 16, 2013

Sponsor

University of Turin, Italy

1. Study Identification

Unique Protocol Identification Number

NCT01771939

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Turin, Italy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epiretinal Membrane

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

idiopathic epiretinal membranes

Arm Type

Experimental

Arm Description

Patients in first arm, with worse visual condition, treated with 25-G Vitrectomy and phacoemulsification (cataract intervention)

Arm Title

idiopathic epiretinal membrane

Arm Type

Active Comparator

Arm Description

Patient in second arm, with better pre-operative condition, treated with phacoemulsification (cataract intervention) only

Intervention Type

Procedure

Intervention Name(s)

25-G vitrectomy and phacoemulsification

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

phacoemulsification (cataract surgery)

Intervention Description

lens extraction after phacoemulsification and intra-ocular artificial lens implantation

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

within 90,180,360,1360 days after surgery

Secondary Outcome Measure Information:

Title

Microperimetry parameters and average macular thickness changes

Description

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

Time Frame

within 90,180,360,1360 days after surgery

10. Eligibility

Sex

All

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Dal Vecchio, MD

Organizational Affiliation

Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy 10100

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Antonio M. Fea, MD, PhD

Organizational Affiliation

Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Carlo A Lavia, MD

Organizational Affiliation

Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinica Oculistica dell'Università, Ospedale Oftalmico

City

Turin

ZIP/Postal Code

10100

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs