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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
3 years

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
no Peeling no peeling used
ICG Peeling indocyanine (ICG) peeling
tb Peeling trypan blue (tb) peeling

Participant Flow:   Overall Study
    no Peeling   ICG Peeling   tb Peeling
STARTED   25   35   18 
COMPLETED   25   34 [1]   18 
NOT COMPLETED   0   1   0 
Physician Decision                0                1                0 
[1] developed cancer during the study



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
no Peeling no peeling used
ICG Peeling indocyanine green (ICG) peeling
tb Peeling trypan blue (tb) peeling
Total Total of all reporting groups

Baseline Measures
   no Peeling   ICG Peeling   tb Peeling   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   35   18   78 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   15   25   10   50 
>=65 years   10   10   8   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.6  (5)   66.9  (5)   66.6  (5)   66.6  (5) 
Gender 
[Units: Participants]
       
Female   20   27   9   56 
Male   5   8   9   22 
Region of Enrollment 
[Units: Participants]
       
Denmark   25   35   18   78 


  Outcome Measures

1.  Primary:   Visual Acuity (ETDRS Letters)   [ Time Frame: Visual acuity at 12 months ]

2.  Secondary:   Anatomic Success   [ Time Frame: macular hole closure at 12 months ]

3.  Secondary:   Visual Field Defects   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
non-closure of macular hole after surgical procedure in 18 patients led to re-operation. Data included in main published papers.


  More Information

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
e-mail: bisan@regionh.dk


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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