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Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

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ClinicalTrials.gov Identifier: NCT00302328
Recruitment Status : Completed
First Posted : March 14, 2006
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Collaborators:
Danish Eye Health Society
The Danish Medical Research Council
Information provided by (Responsible Party):
Ulrik Christensen, Glostrup University Hospital, Copenhagen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Macular Hole
Intervention Procedure: macular hole operation
Enrollment 78
Recruitment Details 3 years
Pre-assignment Details  
Arm/Group Title no Peeling ICG Peeling tb Peeling
Hide Arm/Group Description no peeling used indocyanine (ICG) peeling trypan blue (tb) peeling
Period Title: Overall Study
Started 25 35 18
Completed 25 34 [1] 18
Not Completed 0 1 0
Reason Not Completed
Physician Decision             0             1             0
[1]
developed cancer during the study
Arm/Group Title no Peeling ICG Peeling tb Peeling Total
Hide Arm/Group Description no peeling used indocyanine green (ICG) peeling trypan blue (tb) peeling Total of all reporting groups
Overall Number of Baseline Participants 25 35 18 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 35 participants 18 participants 78 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  60.0%
25
  71.4%
10
  55.6%
50
  64.1%
>=65 years
10
  40.0%
10
  28.6%
8
  44.4%
28
  35.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 35 participants 18 participants 78 participants
67.6  (5) 66.9  (5) 66.6  (5) 66.6  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 35 participants 18 participants 78 participants
Female
20
  80.0%
27
  77.1%
9
  50.0%
56
  71.8%
Male
5
  20.0%
8
  22.9%
9
  50.0%
22
  28.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 25 participants 35 participants 18 participants 78 participants
25 35 18 78
1.Primary Outcome
Title Visual Acuity (ETDRS Letters)
Hide Description Visual acuity measured as the number of ETDRS letters at last follow-up
Time Frame Visual acuity at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Decided from initial power calculation
Arm/Group Title no Peeling ICG Peeling tb Peeling
Hide Arm/Group Description:
Vitrectomy without peeling
vitrectomy with icg-assisted ilm peeling
vitrectomy with trypan blue assisted ilm peeling
Overall Number of Participants Analyzed 25 34 18
Mean (Standard Error)
Unit of Measure: Visual acuity in letters
74.9  (8.2) 72.4  (6.5) 72.2  (9.1)
2.Secondary Outcome
Title Anatomic Success
Hide Description closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
Time Frame macular hole closure at 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
from initial power calculation of primary end point
Arm/Group Title no Peeling ICG Peeling tb Peeling
Hide Arm/Group Description:
vitrectomy without ilm peeling
vitrectomy with icg assited ilm peeling
vitrectomy with trypan blue assited ilm peeling
Overall Number of Participants Analyzed 25 34 18
Measure Type: Number
Unit of Measure: participants
11 32 16
3.Secondary Outcome
Title Visual Field Defects
Hide Description visual field defects measured on humphrey perimetry
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
from predetermined power analysis
Arm/Group Title no Peeling ICG Peeling tb Peeling
Hide Arm/Group Description:
vitrectomy without ilm peeling
vitrectomy with icg assited ilm peeling
vitrectomy with trypan blue assisted ilm peeling
Overall Number of Participants Analyzed 25 34 18
Measure Type: Number
Unit of Measure: participants
0 1 1
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title no Peeling ICG Peeling tb Peeling
Hide Arm/Group Description vitrectomy without ilm peeling vitrectomy with icg assited ilm peeling vitrectomy with trypan blue assited ilm peeling
All-Cause Mortality
no Peeling ICG Peeling tb Peeling
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
no Peeling ICG Peeling tb Peeling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/25 (56.00%)      3/35 (8.57%)      2/18 (11.11%)    
Eye disorders       
macular hole did not close   14/25 (56.00%)  2/35 (5.71%)  2/18 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
cancer *  0/25 (0.00%)  0 1/35 (2.86%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
no Peeling ICG Peeling tb Peeling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/35 (0.00%)      0/18 (0.00%)    
non-closure of macular hole after surgical procedure in 18 patients led to re-operation. Data included in main published papers.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ulrik Christensen
Organization: Glostrup Hospital
Phone: +4538634825
Responsible Party: Ulrik Christensen, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00302328     History of Changes
Other Study ID Numbers: COMAH
First Submitted: March 13, 2006
First Posted: March 14, 2006
Results First Submitted: October 4, 2012
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014