NCT00851760

Brief Summary

The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

February 25, 2009

Last Update Submit

August 3, 2009

Conditions

Epiretinal Macular MembraneCataract Extraction

Outcome Measures

Primary Outcomes (1)

  • Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures.

Study Arms (2)

1 Combined Surgery

EXPERIMENTAL
Procedure: Combined surgery

2 consecutive surgery

ACTIVE COMPARATOR
Procedure: Consecutive surgery

Interventions

Consecutive surgeryPROCEDURE

Consecutive surgery for epiretinal macular membrane and cataract extraction

2 consecutive surgery
Combined surgeryPROCEDURE

Combined surgery for epiretinal macular membrane and cataract extraction

1 Combined Surgery

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients had symptomatic visual loss and needed vitrectomy for ERM removal.

You may not qualify if:

  • Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Unit CHU Dijon

Dijon, Burgundy, 21000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

September 1, 2007

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

FR(1)