Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01771939
Other study ID # VTCMER2
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT03332758 - Inflammasomes in Cell Death in FTMH, ERM, and RRD
Active, not recruiting NCT04130841 - Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery N/A
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Terminated NCT01532765 - Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal N/A
Completed NCT01474655 - Retinal Layers and Visual Rehabilitation After Epiretinal Membrane Removal N/A
Active, not recruiting NCT04120311 - Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole Phase 1
Completed NCT04445142 - Fovea ERM After Fovea-sparing ILM Peeling
Recruiting NCT01701518 - A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes N/A
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT00408720 - Comparison of a Spectral OCT/SLO With the Stratus OCT for Imaging Various Retinal Pathologies N/A
Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
Active, not recruiting NCT04306718 - Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study N/A
Recruiting NCT01985490 - Change in Foveal Avascular Zone After Removal of Epiretinal Membrane and Internal Limiting Membrane N/A
Completed NCT01238393 - Treatment of Epiretinal Membranes With Ranibizumab N/A
Terminated NCT00333060 - Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal Phase 2
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Recruiting NCT05138315 - Quantification of Metamorphopsia in Patients With Epiretinal Membranes N/A
Recruiting NCT03661593 - Aniseikonia in Epiretinal Membrane Patients N/A
Completed NCT03457584 - Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling N/A
Terminated NCT04802265 - EpiRetinal Membrane Peeling and Internal Limiting Membrane