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

Primary Purpose

Idiopathic Macular Hole

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

macular hole operation

About this trial

This is an interventional treatment trial for Idiopathic Macular Hole

Eligibility Criteria

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

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.

Sites / Locations

Department of Ophthalmology, Glostrup Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

macular hole operation no peeling

Macular hole operation ICG peeling

Macular hole operation TB peeling

Arm Description

Outcomes

Primary Outcome Measures

Visual Acuity (ETDRS Letters)

Visual acuity measured as the number of ETDRS letters at last follow-up

Secondary Outcome Measures

Anatomic Success

closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)

Visual Field Defects

visual field defects measured on humphrey perimetry

Full Information

NCT ID

NCT00302328

First Posted

March 13, 2006

Last Updated

March 13, 2014

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

Danish Eye Health Society, The Danish Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00302328

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

Danish Eye Health Society, The Danish Medical Research Council

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Idiopathic Macular Hole

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

macular hole operation no peeling

Arm Type

No Intervention

Arm Title

Macular hole operation ICG peeling

Arm Type

Active Comparator

Arm Title

Macular hole operation TB peeling

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

macular hole operation

Intervention Description

macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling

Primary Outcome Measure Information:

Title

Visual Acuity (ETDRS Letters)

Description

Visual acuity measured as the number of ETDRS letters at last follow-up

Time Frame

Visual acuity at 12 months

Secondary Outcome Measure Information:

Title

Anatomic Success

Description

closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)

Time Frame

macular hole closure at 12 months

Title

Visual Field Defects

Description

visual field defects measured on humphrey perimetry

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morten la Cour, MD,DMSc,EBOD

Organizational Affiliation

Glostrup Hospital, Department of Ophthalmology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Michael Larsen, MD, DMSc

Organizational Affiliation

Glostrup Hospital, Department of Ophthalmology

Official's Role

Study Director

Facility Information:

Facility Name

Department of Ophthalmology, Glostrup Hospital

City

Copenhagen

ZIP/Postal Code

DK-2600

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

19912135

Citation

Christensen UC. Value of internal limiting membrane peeling in surgery for idiopathic macular hole and the correlation between function and retinal morphology. Acta Ophthalmol. 2009 Dec;87 Thesis 2:1-23. doi: 10.1111/j.1755-3768.2009.01777.x.

Results Reference

derived

PubMed Identifier

19692379

Citation

Christensen UC, Kroyer K, Sander B, Jorgensen TM, Larsen M, la Cour M. Macular morphology and visual acuity after macular hole surgery with or without internal limiting membrane peeling. Br J Ophthalmol. 2010 Jan;94(1):41-7. doi: 10.1136/bjo.2009.159582. Epub 2009 Aug 18.

Results Reference

derived

PubMed Identifier

19578018

Citation

Kroyer K, Christensen U, la Cour M, Larsen M. Metamorphopsia assessment before and after vitrectomy for macular hole. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5511-5. doi: 10.1167/iovs.09-3530. Epub 2009 Jul 2.

Results Reference

derived

PubMed Identifier

19028741

Citation

Christensen UC, Kroyer K, Sander B, Larsen M, Henning V, Villumsen J, la Cour M. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial. Br J Ophthalmol. 2009 Aug;93(8):1005-15. doi: 10.1136/bjo.2008.151266. Epub 2008 Nov 21.

Results Reference

derived

PubMed Identifier

18450594

Citation

Kroyer K, Christensen U, Larsen M, la Cour M. Quantification of metamorphopsia in patients with macular hole. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3741-6. doi: 10.1167/iovs.07-1452. Epub 2008 Apr 30.

Results Reference

derived

Learn more about this trial

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

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