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Trial record 28 of 1614 for:    glaucoma

Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

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: NCT00869141
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : June 17, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Simon Law, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glaucoma
Intervention Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Research Arm Standard of Care Arm
Hide Arm/Group Description

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Period Title: Overall Study
Started 26 26
Completed 26 26
Not Completed 0 0
Arm/Group Title Research Arm Standard of Care Arm Total
Hide Arm/Group Description

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 52 participants
67.5  (11.6) 61.6  (15.3) 64.3  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
13
  50.0%
11
  42.3%
24
  46.2%
Male
13
  50.0%
15
  57.7%
28
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Hispanic or Latino
3
  11.5%
5
  19.2%
8
  15.4%
Not Hispanic or Latino
23
  88.5%
21
  80.8%
44
  84.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  19.2%
10
  38.5%
15
  28.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  11.5%
0
   0.0%
3
   5.8%
White
18
  69.2%
16
  61.5%
34
  65.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma
Hide Description Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week
Time Frame within 6 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Research Arm Standard of Care Arm
Hide Arm/Group Description:

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Overall Number of Participants Analyzed 26 26
Measure Type: Number
Unit of Measure: participants
9 12
2.Primary Outcome
Title Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
Hide Description intraocular pressure comparison between groups after the Ahmed valve implantation
Time Frame 3 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Eye pressure at postop 3-week is reported
Arm/Group Title Research Arm Standard of Care Arm
Hide Arm/Group Description:

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: mmHg at postop 3-week
15.6  (3.6) 20.6  (8.9)
3.Primary Outcome
Title Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase
Hide Description intraocular pressure of eyes with hypertensive phase versus without hypertensive phase
Time Frame 1 year after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.
Arm/Group Title Hypertensive Phase Group Non-hypertensive Phase Group
Hide Arm/Group Description:
Eyes that developed hypertensive phase after Ahmed valve implantation
Eyes that did not develop hypertensive phase after Ahmed valve implantation
Overall Number of Participants Analyzed 21 31
Mean (Standard Deviation)
Unit of Measure: mmHg in 1 year postop
15.1  (5.2) 11.4  (4.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Research Arm Standard of Care Arm
Hide Arm/Group Description

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation

All-Cause Mortality
Research Arm Standard of Care Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Research Arm Standard of Care Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Research Arm Standard of Care Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      2/26 (7.69%)    
Eye disorders     
Uveitis and conreal edema *  0/26 (0.00%)  0 2/26 (7.69%)  2
Strabismus *  1/26 (3.85%)  1 0/26 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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: Dr. Simon K. Law
Organization: Stein Eye Institute
Phone: (310)794-1477
Responsible Party: Simon Law, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00869141     History of Changes
Other Study ID Numbers: UCLA IRB#08-10-110-01
First Submitted: March 24, 2009
First Posted: March 25, 2009
Results First Submitted: June 1, 2015
Results First Posted: June 17, 2015
Last Update Posted: December 30, 2015