Trial Outcomes & Findings for Ahmed Versus Baerveldt Comparison Study (NCT NCT00376363)

Results Overview

intraocular pressure mmHg at 5 years

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

276 participants

Primary outcome timeframe

5 years

Results posted on

2015-08-20

Participant Flow

A total of 276 patients were enrolled between November 2005 and April 2008: 143 in the Ahmed group and 133 in the Baerveldt group at 16 clinical centers worldwide.

Participant milestones

Participant milestones
Measure	Ahmed Implant,1 Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press
Overall Study STARTED	143	133
Overall Study COMPLETED	87	87
Overall Study NOT COMPLETED	56	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ahmed Versus Baerveldt Comparison Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ahmed Implant,1 n=143 Participants Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant n=133 Participants Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press	Total n=276 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 12.8 • n=5 Participants	62.2 years STANDARD_DEVIATION 14.2 • n=7 Participants	63.8 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	63 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	70 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

intraocular pressure mmHg at 5 years

Outcome measures

Outcome measures
Measure	Ahmed Implant,1 n=87 Participants Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant n=87 Participants Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press
Intraocular Pressure	14.7 mm Hg Standard Deviation 4.4	12.7 mm Hg Standard Deviation 4.5

PRIMARY outcome

Timeframe: 5 years

Population: Kaplan-Meier survival analysis

5-year failure rate measured by Kaplan-Meier, defined as IOP\>21 mm Hg or less than a 20% reduction below baseline on 2 consecutive study visits after 3 months, reoperation for glaucoma, loss of light perception, or removal of implant

Outcome measures

Outcome measures
Measure	Ahmed Implant,1 n=143 Participants Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant n=133 Participants Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press
Failure Rate	80 percent fail	53 percent fail

SECONDARY outcome

Timeframe: 5 years

Population: The failure rate is based on Kaplan Meier analysis of all patients enrolled (n=276). The five-year intraocular pressure and visual acuity outcomes are based on those patients who received a five-year visit (n=174 for IOP; n=173 for visual acuity, 1 patient had missing data)

Snellen chart converted to logMAR (smaller logMAR values indicate better visual acuity logMar of 0 is Snellen 20/20; logMAR of 20/200 is 1.0)

Outcome measures

Outcome measures
Measure	Ahmed Implant,1 n=86 Participants Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant n=87 Participants Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press
Visual Acuity	1.42 logMAR Standard Deviation 1.15	1.43 logMAR Standard Deviation 1.40

Adverse Events

Ahmed Implant,1

Serious events: 9 serious events

Other events: 30 other events

Deaths: 0 deaths

Baerveldt Implant

Serious events: 16 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ahmed Implant,1 n=143 participants at risk Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant n=133 participants at risk Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press
Eye disorders loss of light perception	6.3% 9/143 • 5 year	12.0% 16/133 • 5 year

Other adverse events

Other adverse events
Measure	Ahmed Implant,1 n=143 participants at risk Ahmed glaucoma drainage implant for intraocular pressure control Ahmed implant: placement of glaucoma drainage device to control intraocular pressure	Baerveldt Implant n=133 participants at risk Baerveldt glaucoma drainage implant for intraocular pressure control Baerveldt implant: placement of glaucoma drainage device to control intraocular press
Eye disorders diplopia	11.2% 16/143 • 5 year	10.5% 14/133 • 5 year
Eye disorders corneal edema	9.8% 14/143 • 5 year	11.3% 15/133 • 5 year

Additional Information

Donald Budenz

University of North Carolina

Phone: 919-843-0297

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place