Idiopathic Macular Hole
Conditions
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.
Interventions
PROCEDUREmacular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Sponsors
Danish Eye Health Society
The Danish Medical Research Council
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (ETDRS Letters) | Visual acuity at 12 months | Visual acuity measured as the number of ETDRS letters at last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic Success | macular hole closure at 12 months | closure of the macular hole evaluated on optical coherence tomography 3 (OCT3) |
| Visual Field Defects | 6 months | visual field defects measured on humphrey perimetry |
Countries
Denmark
Participant flow
Recruitment details
3 years
Participants by arm
| Arm | Count |
|---|---|
| no Peeling no peeling used | 25 |
| ICG Peeling indocyanine green (ICG) peeling | 35 |
| tb Peeling trypan blue (tb) peeling | 18 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | ICG Peeling | tb Peeling | no Peeling | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 8 Participants | 10 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 10 Participants | 15 Participants | 50 Participants |
| Age, Continuous | 66.9 years STANDARD_DEVIATION 5 | 66.6 years STANDARD_DEVIATION 5 | 67.6 years STANDARD_DEVIATION 5 | 66.6 years STANDARD_DEVIATION 5 |
| Region of Enrollment Denmark | 35 participants | 18 participants | 25 participants | 78 participants |
| Sex: Female, Male Female | 27 Participants | 9 Participants | 20 Participants | 56 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 5 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 35 | 0 / 18 |
| serious Total, serious adverse events | 14 / 25 | 3 / 35 | 2 / 18 |
Outcome results
Primary
Visual Acuity (ETDRS Letters)
Visual acuity measured as the number of ETDRS letters at last follow-up
Time frame: Visual acuity at 12 months
Population: Decided from initial power calculation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| no Peeling | Visual Acuity (ETDRS Letters) | 74.9 Visual acuity in letters | Standard Error 8.2 |
| ICG Peeling | Visual Acuity (ETDRS Letters) | 72.4 Visual acuity in letters | Standard Error 6.5 |
| tb Peeling | Visual Acuity (ETDRS Letters) | 72.2 Visual acuity in letters | Standard Error 9.1 |
Secondary
Anatomic Success
closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
Time frame: macular hole closure at 12 months
Population: from initial power calculation of primary end point
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| no Peeling | Anatomic Success | 11 participants | 31 |
| ICG Peeling | Anatomic Success | 32 participants | — |
| tb Peeling | Anatomic Success | 16 participants | — |
Secondary
Visual Field Defects
visual field defects measured on humphrey perimetry
Time frame: 6 months
Population: from predetermined power analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| no Peeling | Visual Field Defects | 0 participants |
| ICG Peeling | Visual Field Defects | 1 participants |
| tb Peeling | Visual Field Defects | 1 participants |