Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes
NCT ID: NCT00302328
Last Updated: 2014-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2005-08-31
2009-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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macular hole operation no peeling
No interventions assigned to this group
Macular hole operation ICG peeling
macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Macular hole operation TB peeling
macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Interventions
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macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Eligibility Criteria
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Inclusion Criteria
* Duration of Symptoms ≤ 12 months.
* Visual acuity ≥ 34 ETDRS letters.
* Intraocular pressure ≤ 23 mmHg.
* Informed consent.
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Danish Eye Health Society
OTHER
The Danish Medical Research Council
OTHER
Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Ulrik Christensen
MD
Principal Investigators
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Morten la Cour, MD,DMSc,EBOD
Role: STUDY_DIRECTOR
Glostrup Hospital, Department of Ophthalmology
Michael Larsen, MD, DMSc
Role: STUDY_DIRECTOR
Glostrup Hospital, Department of Ophthalmology
Locations
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Department of Ophthalmology, Glostrup Hospital
Copenhagen, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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COMAH
Identifier Type: -
Identifier Source: org_study_id
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