Clinical trial NCT00302328: 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
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Macular Hole
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Eye Health Society
name: The Danish Medical Research Council
First posted: 2006-03-14
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Visual Acuity (ETDRS Letters)
timeFrame: Visual acuity at 12 months
Secondary outcomes:
measure: Anatomic Success
timeFrame: macular hole closure at 12 months
measure: Visual Field Defects
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Ophthalmology, Glostrup Hospital
Study officials:
affiliation: Glostrup Hospital, Department of Ophthalmology
name: Morten la Cour, MD,DMSc,EBOD
role: STUDY_DIRECTOR
affiliation: Glostrup Hospital, Department of Ophthalmology
name: Michael Larsen, MD, DMSc
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.