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

NCT00302328 | Completed Results

• 1 other identifier: COMAH
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Macular Hole

Outcome Measures

Primary Outcomes (1)

• Visual Acuity (ETDRS Letters)

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

  Visual acuity at 12 months

Secondary Outcomes (2)

• Anatomic Success

  macular hole closure at 12 months

• Visual Field Defects

  6 months

Study Arms (3)

macular hole operation no peeling

NO INTERVENTION

Macular hole operation ICG peeling

ACTIVE COMPARATOR

Procedure: macular hole operation

Macular hole operation TB peeling

EXPERIMENTAL

Procedure: macular hole operation

Interventions

macular hole operation PROCEDURE

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

Macular hole operation ICG peeling; Macular hole operation TB peeling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• Danish Eye Health Society: collaborator
• The Danish Medical Research Council: collaborator

Study Sites (1)

Department of Ophthalmology, Glostrup Hospital

Copenhagen, DK-2600, Denmark

Location

Related Publications (5)

• 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.

  PMID: 19912135 DERIVED

• 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.

  PMID: 19692379 DERIVED

• 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.

  PMID: 19578018 DERIVED

• 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.

  PMID: 19028741 DERIVED

• 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.

  PMID: 18450594 DERIVED

Limitations and Caveats

non-closure of macular hole after surgical procedure in 18 patients led to re-operation. Data included in main published papers.

Results Point of Contact

• Title: Ulrik Christensen
• Organization: Glostrup Hospital

bisan@regionh.dk

+4538634825

Study Officials

• Morten la Cour, MD,DMSc,EBOD

  Glostrup Hospital, Department of Ophthalmology

  STUDY DIRECTOR

• Michael Larsen, MD, DMSc

  Glostrup Hospital, Department of Ophthalmology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: August 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2009
• Last Updated: April 16, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-03

Locations

DK (1)