Trial Outcomes & Findings for Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent (NCT NCT03647033)

NCT ID: NCT03647033

Last Updated: 2018-10-31

Results Overview

change in mean unmedicated intraocular pressure between baseline and 1 year

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-10-31

Participant Flow

Participant milestones

Measure	Phacoemulsification Alone routine phacoemulsification cataract surgery with intraocular lens implantation	Phacoemulsification and iStent 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 Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Baseline characteristics by cohort

Measure	Phacoemulsification Alone n=16 Participants routine phacoemulsification cataract surgery with intraocular lens implantation	Phacoemulsification and iStent n=16 Participants 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 n=32 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	65 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Singapore	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: intraocular pressure of participants measured in mmHg

change in mean unmedicated intraocular pressure between baseline and 1 year

Outcome measures

Measure	Phacoemulsification Alone n=16 Participants routine phacoemulsification cataract surgery with intraocular lens implantation	Phacoemulsification and iStent n=16 Participants 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.
Change in Intraocular Pressure Between Baseline and 1 Year	15 mmHg Standard Deviation 2.5	14.7 mmHg Standard Deviation 3.1

SECONDARY outcome

Timeframe: 1 year

change in number of topical glaucoma medications at 1 year post operation

Outcome measures

Measure	Phacoemulsification Alone n=16 Participants routine phacoemulsification cataract surgery with intraocular lens implantation	Phacoemulsification and iStent n=16 Participants 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.
Change in Glaucoma Medications	0.75 number of glaucoma medications Standard Deviation 1.0	0.25 number of glaucoma medications Standard Deviation 0.68

Adverse Events

Phacoemulsification Alone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Phacoemulsification and iStent

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Phacoemulsification Alone n=16 participants at risk routine phacoemulsification cataract surgery with intraocular lens implantation	Phacoemulsification and iStent n=16 participants at risk 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.
Eye disorders intraoperative hyphema	0.00% 0/16 • 1 year	37.5% 6/16 • Number of events 6 • 1 year
Eye disorders intraoperative iris prolapse	6.2% 1/16 • Number of events 1 • 1 year	12.5% 2/16 • Number of events 2 • 1 year
Eye disorders intraoperative iris trauma	6.2% 1/16 • Number of events 1 • 1 year	6.2% 1/16 • Number of events 1 • 1 year
Eye disorders intraoperative iridodialysis	0.00% 0/16 • 1 year	6.2% 1/16 • Number of events 1 • 1 year

Additional Information

Dr. David Chen

National University Hospital

Phone: +6594550281

Email: david_chen@nuhs.edu.sg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place