Trial Outcomes & Findings for Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes (NCT NCT00302328)
NCT ID: NCT00302328
Last Updated: 2014-04-16
Results Overview
Visual acuity measured as the number of ETDRS letters at last follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Visual acuity at 12 months
Results posted on
2014-04-16
Participant Flow
3 years
Participant milestones
| Measure |
no Peeling
no peeling used
|
ICG Peeling
indocyanine (ICG) peeling
|
tb Peeling
trypan blue (tb) peeling
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
35
|
18
|
|
Overall Study
COMPLETED
|
25
|
34
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
no Peeling
no peeling used
|
ICG Peeling
indocyanine (ICG) peeling
|
tb Peeling
trypan blue (tb) peeling
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes
Baseline characteristics by cohort
| Measure |
no Peeling
n=25 Participants
no peeling used
|
ICG Peeling
n=35 Participants
indocyanine green (ICG) peeling
|
tb Peeling
n=18 Participants
trypan blue (tb) peeling
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 5 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 5 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 5 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
25 participants
n=5 Participants
|
35 participants
n=7 Participants
|
18 participants
n=5 Participants
|
78 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Visual acuity at 12 monthsPopulation: Decided from initial power calculation
Visual acuity measured as the number of ETDRS letters at last follow-up
Outcome measures
| Measure |
no Peeling
n=25 Participants
Vitrectomy without peeling
|
ICG Peeling
n=34 Participants
vitrectomy with icg-assisted ilm peeling
|
tb Peeling
n=18 Participants
vitrectomy with trypan blue assisted ilm peeling
|
|---|---|---|---|
|
Visual Acuity (ETDRS Letters)
|
74.9 Visual acuity in letters
Standard Error 8.2
|
72.4 Visual acuity in letters
Standard Error 6.5
|
72.2 Visual acuity in letters
Standard Error 9.1
|
SECONDARY outcome
Timeframe: macular hole closure at 12 monthsPopulation: from initial power calculation of primary end point
closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
Outcome measures
| Measure |
no Peeling
n=25 Participants
Vitrectomy without peeling
|
ICG Peeling
n=34 Participants
vitrectomy with icg-assisted ilm peeling
|
tb Peeling
n=18 Participants
vitrectomy with trypan blue assisted ilm peeling
|
|---|---|---|---|
|
Anatomic Success
|
11 participants
31
|
32 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: from predetermined power analysis
visual field defects measured on humphrey perimetry
Outcome measures
| Measure |
no Peeling
n=25 Participants
Vitrectomy without peeling
|
ICG Peeling
n=34 Participants
vitrectomy with icg-assisted ilm peeling
|
tb Peeling
n=18 Participants
vitrectomy with trypan blue assisted ilm peeling
|
|---|---|---|---|
|
Visual Field Defects
|
0 participants
Interval 0.0 to 0.1
|
1 participants
|
1 participants
|
Adverse Events
no Peeling
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
ICG Peeling
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
tb Peeling
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
no Peeling
n=25 participants at risk
vitrectomy without ilm peeling
|
ICG Peeling
n=35 participants at risk
vitrectomy with icg assited ilm peeling
|
tb Peeling
n=18 participants at risk
vitrectomy with trypan blue assited ilm peeling
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer
|
0.00%
0/25 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
0.00%
0/18 • 12 months
|
|
Eye disorders
macular hole did not close
|
56.0%
14/25 • 12 months
|
5.7%
2/35 • 12 months
|
11.1%
2/18 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place