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Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

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ClinicalTrials.gov Identifier: NCT03647033
Recruitment Status : Completed
First Posted : August 27, 2018
Results First Posted : October 2, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Khoo Teck Puat Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Primary Angle-Closure Glaucoma
Primary Angle Closure Without Glaucoma Damage
Intervention Device: iStent implantation
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phacoemulsification Alone Phacoemulsification and iStent
Hide Arm/Group Description routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Phacoemulsification Alone Phacoemulsification and iStent Total
Hide Arm/Group Description routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
69
(64.3 to 76.8)
65
(62 to 67)
67
(63 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
9
  56.3%
6
  37.5%
15
  46.9%
Male
7
  43.8%
10
  62.5%
17
  53.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
16
 100.0%
16
 100.0%
32
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
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%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Singapore Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Change in Intraocular Pressure Between Baseline and 1 Year
Hide Description change in mean unmedicated intraocular pressure between baseline and 1 year
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
intraocular pressure of participants measured in mmHg
Arm/Group Title Phacoemulsification Alone Phacoemulsification and iStent
Hide Arm/Group Description:
routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mmHg
15  (2.5) 14.7  (3.1)
2.Secondary Outcome
Title Change in Glaucoma Medications
Hide Description change in number of topical glaucoma medications at 1 year post operation
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phacoemulsification Alone Phacoemulsification and iStent
Hide Arm/Group Description:
routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: number of glaucoma medications
0.75  (1.0) 0.25  (0.68)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phacoemulsification Alone Phacoemulsification and iStent
Hide Arm/Group Description routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

All-Cause Mortality
Phacoemulsification Alone Phacoemulsification and iStent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Phacoemulsification Alone Phacoemulsification and iStent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phacoemulsification Alone Phacoemulsification and iStent
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      10/16 (62.50%)    
Eye disorders     
intraoperative hyphema * 1  0/16 (0.00%)  0 6/16 (37.50%)  6
intraoperative iris prolapse *  1/16 (6.25%)  1 2/16 (12.50%)  2
intraoperative iris trauma *  1/16 (6.25%)  1 1/16 (6.25%)  1
intraoperative iridodialysis *  0/16 (0.00%)  0 1/16 (6.25%)  1
1
Term from vocabulary, hyphema
*
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
Layout table for Results Point of Contact information
Name/Title: Dr. David Chen
Organization: National University Hospital
Phone: +6594550281
EMail: david_chen@nuhs.edu.sg
Layout table for additonal information
Responsible Party: Khoo Teck Puat Hospital
ClinicalTrials.gov Identifier: NCT03647033     History of Changes
Other Study ID Numbers: 2015/00644
First Submitted: August 23, 2018
First Posted: August 27, 2018
Results First Submitted: September 5, 2018
Results First Posted: October 2, 2018
Last Update Posted: October 31, 2018