Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

This study has been completed.
Sponsor:
Collaborators:
Danish Eye Health Society
The Danish Medical Research Council
Information provided by (Responsible Party):
Ulrik Christensen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00302328
First received: March 13, 2006
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered.

Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.


Condition Intervention
Idiopathic Macular Hole
Procedure: macular hole operation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Visual Acuity (ETDRS Letters) [ Time Frame: Visual acuity at 12 months ] [ Designated as safety issue: No ]
    Visual acuity measured as the number of ETDRS letters at last follow-up


Secondary Outcome Measures:
  • Anatomic Success [ Time Frame: macular hole closure at 12 months ] [ Designated as safety issue: No ]
    closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)

  • Visual Field Defects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    visual field defects measured on humphrey perimetry


Enrollment: 78
Study Start Date: August 2005
Study Completion Date: January 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: macular hole operation no peeling
Active Comparator: Macular hole operation ICG peeling Procedure: macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Experimental: Macular hole operation TB peeling Procedure: macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic macular hele stage 2 or 3.
  • Duration of Symptoms ≤ 12 months.
  • Visual acuity ≥ 34 ETDRS letters.
  • Intraocular pressure ≤ 23 mmHg.
  • Informed consent.

Exclusion Criteria:

  • Previous macular hole in project eye
  • Macular pucker worse than a cellophane macular reflex.
  • Previous surgery or disease in the eye affecting retinal function.
  • Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a.
  • Amblyopia i project eye.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302328

Locations
Denmark
Department of Ophthalmology, Glostrup Hospital
Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Danish Eye Health Society
The Danish Medical Research Council
Investigators
Study Director: Morten la Cour, MD,DMSc,EBOD Glostrup Hospital, Department of Ophthalmology
Study Director: Michael Larsen, MD, DMSc Glostrup Hospital, Department of Ophthalmology
  More Information

No publications provided by Glostrup University Hospital, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrik Christensen, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00302328     History of Changes
Other Study ID Numbers: COMAH
Study First Received: March 13, 2006
Results First Received: October 4, 2012
Last Updated: March 13, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014