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Trial record 100 of 1614 for:    glaucoma

Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00538590
Recruitment Status : Completed
First Posted : October 2, 2007
Results First Posted : April 25, 2012
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Open Angle Glaucoma
Interventions Device: Collagen Matrix in Glaucoma Filtering Surgery
Drug: Mitomycin-C(MMC) and glaucoma filtering surgery
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description Application of Mitomycin-C in trabeculectomy to reduce super-scarring. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Period Title: Overall Study
Started 10 10
Completed 9 [1] 10
Not Completed 1 0
Reason Not Completed
Death             1             0
[1]
Deceased 8 months after surgery due to known cardiovascular co-morbidity.
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen) Total
Hide Arm/Group Description Application of Mitomycin-C in trabeculectomy to reduce super-scarring. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  50.0%
5
  50.0%
10
  50.0%
>=65 years
5
  50.0%
5
  50.0%
10
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
60.6  (9.4) 64.9  (8.6) 62.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
6
  60.0%
12
  60.0%
Male
4
  40.0%
4
  40.0%
8
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Postoperative Intraocular Pressure Change
Hide Description Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Time Frame 360 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description:
Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
-11.3  (8.7) -11.6  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MITOMYCIN-C, Ologen (Oculusgen)
Comments Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Postoperative Intraocular Pressure Change
Hide Description Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description:
Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
-11.8  (6.1) -11.8  (11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MITOMYCIN-C, Ologen (Oculusgen)
Comments Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Postoperative Intraocular Pressure Change
Hide Description Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description:
Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
-10.9  (5.8) -14.1  (10.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MITOMYCIN-C, Ologen (Oculusgen)
Comments Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Postoperative Intraocular Pressure Change
Hide Description Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description:
Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
-13.3  (6.4) -12.9  (8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MITOMYCIN-C, Ologen (Oculusgen)
Comments Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Complications
Hide Description Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.
Time Frame 360 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description:
Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: percentage of participants
15.6  (10.1) 15.6  (20.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MITOMYCIN-C Ologen (Oculusgen)
Hide Arm/Group Description Application of Mitomycin-C in trabeculectomy to reduce super-scarring. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
All-Cause Mortality
MITOMYCIN-C Ologen (Oculusgen)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MITOMYCIN-C Ologen (Oculusgen)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/10 (0.00%)    
Cardiac disorders     
Death  1/10 (10.00%)  1 0/10 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MITOMYCIN-C Ologen (Oculusgen)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Thomas Dietlein, Ph. D., MD
Organization: Hospital of Universität Köln
Phone: +49 221 4785862 ext 4300
Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00538590     History of Changes
Other Study ID Numbers: ologen-Koln
First Submitted: September 29, 2007
First Posted: October 2, 2007
Results First Submitted: January 19, 2012
Results First Posted: April 25, 2012
Last Update Posted: April 25, 2012