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| Name | Class |
|---|---|
| Danish Eye Health Society | OTHER |
| The Danish Medical Research Council | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| macular hole operation no peeling | No Intervention | ||
| Macular hole operation ICG peeling | Active Comparator |
| |
| Macular hole operation TB peeling | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| macular hole operation | Procedure | macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (ETDRS Letters) | Visual acuity measured as the number of ETDRS letters at last follow-up | Visual acuity at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomic Success | closure of the macular hole evaluated on optical coherence tomography 3 (OCT3) | macular hole closure at 12 months |
| Visual Field Defects | visual field defects measured on humphrey perimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morten la Cour, MD,DMSc,EBOD | Glostrup Hospital, Department of Ophthalmology | Study Director |
| Michael Larsen, MD, DMSc | Glostrup Hospital, Department of Ophthalmology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Glostrup Hospital | Copenhagen | DK-2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19912135 | Derived | 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. | |
| 19692379 | 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. |
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3 years
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| ID | Title | Description |
|---|---|---|
| FG000 | no Peeling | no peeling used |
| FG001 | ICG Peeling | indocyanine (ICG) peeling |
| FG002 | tb Peeling | trypan blue (tb) peeling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Peeling | no peeling used |
| BG001 | ICG Peeling | indocyanine green (ICG) peeling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity (ETDRS Letters) | Visual acuity measured as the number of ETDRS letters at last follow-up | Decided from initial power calculation | Posted | Mean | Standard Error | Visual acuity in letters | Visual acuity at 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | no Peeling | vitrectomy without ilm peeling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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non-closure of macular hole after surgical procedure in 18 patients led to re-operation. Data included in main published papers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulrik Christensen | Glostrup Hospital | +4538634825 | bisan@regionh.dk |
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| 6 months |
| 19578018 | 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. |
| 19028741 | 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. |
| 18450594 | 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. |
| BG002 |
| tb Peeling |
trypan blue (tb) peeling |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Anatomic Success | closure of the macular hole evaluated on optical coherence tomography 3 (OCT3) | from initial power calculation of primary end point | Posted | Number | participants | macular hole closure at 12 months |
|
|
|
| Secondary | Visual Field Defects | visual field defects measured on humphrey perimetry | from predetermined power analysis | Posted | Number | participants | 6 months |
|
|
|
| 14 |
| 25 |
| 0 |
| 25 |
| EG001 | ICG Peeling | vitrectomy with icg assited ilm peeling | 3 | 35 | 0 | 35 |
| EG002 | tb Peeling | vitrectomy with trypan blue assited ilm peeling | 2 | 18 | 0 | 18 |
| macular hole did not close | Eye disorders | Systematic Assessment |
|
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