An interventional study of macular hole operation in Idiopathic Macular Hole, sponsored by Glostrup University Hospital, Copenhagen. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2014-04-16.
Sponsored by Glostrup University Hospital, Copenhagen · Not applicable, Interventional, and Treatment
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.
Glostrup University Hospital, Copenhagen is the lead sponsor of 106 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Procedure: macular hole operation
Procedure: macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Visual Acuity (ETDRS Letters)
Visual acuity measured as the number of ETDRS letters at last follow-up
Time frame: Visual acuity at 12 months
Anatomic Success
closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
Time frame: macular hole closure at 12 months
Visual Field Defects
visual field defects measured on humphrey perimetry
Time frame: 6 months
3 years
| Milestone | no Peeling | ICG Peeling | tb Peeling |
|---|---|---|---|
| Started | 25 | 35 | 18 |
| Completed | 25 | 34 | 18 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
Visual acuity measured as the number of ETDRS letters at last follow-up
| Visual acuity in letters | no Peeling | ICG Peeling | tb Peeling |
|---|---|---|---|
| Visual Acuity (ETDRS Letters) | 74.9 ± 8.2 | 72.4 ± 6.5 | 72.2 ± 9.1 |
closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
| participants | no Peeling | ICG Peeling | tb Peeling |
|---|---|---|---|
| Anatomic Success | 11 ± 31 | 32 | 16 |
visual field defects measured on humphrey perimetry
| participants | no Peeling | ICG Peeling | tb Peeling |
|---|---|---|---|
| Visual Field Defects | 0 (0 to .1) | 1 | 1 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| no Peeling | — | 14/25 (56%) | 0/25 (0%) |
| ICG Peeling | — | 3/35 (8.6%) | 0/35 (0%) |
| tb Peeling | — | 2/18 (11.1%) | 0/18 (0%) |
| Event | no Peeling | ICG Peeling | tb Peeling |
|---|---|---|---|
| macular hole did not closeEye disorders | 14/25 | 2/35 | 2/18 |
| cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/25 | 1/35 | 0/18 |
| Age, Categorical(Participants) | no Peeling | ICG Peeling | tb Peeling | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 25 | 10 | 50 |
| >=65 years | 10 | 10 | 8 | 28 |
| Age, Continuous(years) | no Peeling | ICG Peeling | tb Peeling | Total |
|---|---|---|---|---|
| Mean | 67.6 ± 5 | 66.9 ± 5 | 66.6 ± 5 | 66.6 ± 5 |
| Sex: Female, Male(Participants) | no Peeling | ICG Peeling | tb Peeling | Total |
|---|---|---|---|---|
| Female | 20 | 27 | 9 | 56 |
| Male | 5 | 8 | 9 | 22 |
| Region of Enrollment(participants) | no Peeling | ICG Peeling | tb Peeling | Total |
|---|---|---|---|---|
| Denmark | 25 | 35 | 18 | 78 |
The record gives a start of Aug 2005, a primary completion of Jan 2008 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2014, 6 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Glostrup University Hospital, Copenhagen →