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Completed

NCT Number: NCT00302328

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

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.

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Key information

Conditions

Idiopathic Macular Hole

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Glostrup Hospital

Copenhagen, DK-2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

macular hole operation

Procedure

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

Primary outcomes

  1. Visual Acuity (ETDRS Letters)

    Time frame: Visual acuity at 12 months

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

Secondary outcomes

  1. Anatomic Success

    Time frame: macular hole closure at 12 months

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

  2. Visual Field Defects

    Time frame: 6 months

    visual field defects measured on humphrey perimetry

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • Danish Eye Health Society
  • The Danish Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Mar 14, 2006
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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