Trial Outcomes & Findings for Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma (NCT NCT04542616)
NCT ID: NCT04542616
Last Updated: 2026-04-17
Results Overview
Mean IOP in each treatment group at the above time points
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, Month 1, Month 3, Month 6, Month 12, Month 24
Results posted on
2026-04-17
Participant Flow
All patients over the age of 18 years in the glaucoma department seen by Dr. Asher Weiner were recruited for the study. They then underwent screening for eligibility according to inclusion/exclusion criteria in the study protocol.
Participants were screened for eligibility according to the study inclusion and exclusion criteria. After consent, participants underwent a baseline ophthalmic evaluation and relevant imaging as per protocol. Eligible participants were then randomized to receive either the Baerveldt 350 mm² glaucoma drainage device or the Ahmed ClearPath 250 mm² device. Randomization was stratified at the patient level, and each eye was treated as an independent unit if both eyes qualified and were enrolled.
Unit of analysis: Eye
Participant milestones
| Measure |
Baerveldt 350
The eye in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
|
Ahmed ClearPath 250
The eye in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
|
|---|---|---|
|
Overall Study
STARTED
|
38 38
|
40 40
|
|
Overall Study
COMPLETED
|
38 38
|
40 40
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
Baseline characteristics by cohort
| Measure |
Baerveldt 350
n=38 Eyes
Intervention Type: Device
Intervention Name: Baerveldt Glaucoma Implant 350 mm²
Description: Eyes randomized to this arm underwent implantation of the Baerveldt 350 mm² glaucoma drainage device (non-valved). The procedure was performed by a single glaucoma surgeon according to standard surgical technique. Postoperative care, including topical and systemic medications, was administered per standard clinical practice.
|
Ahmed ClearPath 250
n=40 Eyes
Intervention Type: Device
Intervention Name: Ahmed ClearPath 250 mm² Glaucoma Drainage Device
Description: Eyes randomized to this arm underwent implantation of the Ahmed ClearPath 250 mm² glaucoma drainage device (non-valved). The procedure was performed by a single glaucoma surgeon according to standard surgical technique. Postoperative care, including topical and systemic medications, was administered per standard clinical practice.
|
Total
n=78 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Eyes
n=38 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
0 Eyes
n=40 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
0 Eyes
n=78 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
|
Age, Categorical
Between 18 and 65 years
|
8 Eyes
n=38 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
8 Eyes
n=40 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
16 Eyes
n=78 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
|
Age, Categorical
>=65 years
|
30 Eyes
n=38 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
32 Eyes
n=40 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
62 Eyes
n=78 Eyes • There are participants who may have each eye in different treatment arms. In cases where both eyes of an individual patient met eligibility criteria, both eyes were allowed to be enrolled and randomized. Randomization was performed at the eye level, and eyes from the same participant could be assigned to different treatment arms.
|
|
Sex: Female, Male
Female
|
17 Eyes
n=38 Eyes
|
19 Eyes
n=40 Eyes
|
36 Eyes
n=78 Eyes
|
|
Sex: Female, Male
Male
|
21 Eyes
n=38 Eyes
|
21 Eyes
n=40 Eyes
|
42 Eyes
n=78 Eyes
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=38 Participants
|
13 Participants
n=40 Participants
|
31 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=38 Participants
|
10 Participants
n=40 Participants
|
15 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Unspecified (Not Hispanic or Latino)
|
3 Participants
n=38 Participants
|
3 Participants
n=40 Participants
|
6 Participants
n=78 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
12 Participants
n=38 Participants
|
14 Participants
n=40 Participants
|
26 Participants
n=78 Participants
|
|
Mean Preop IOP (mmHg)
|
22.50 mmHg
STANDARD_DEVIATION 8.97 • n=38 Eyes
|
20.32 mmHg
STANDARD_DEVIATION 6.67 • n=40 Eyes
|
21.36 mmHg
STANDARD_DEVIATION 7.87 • n=78 Eyes
|
|
Glaucoma Stage
Mild
|
0 Eyes
n=38 Eyes
|
1 Eyes
n=40 Eyes
|
1 Eyes
n=78 Eyes
|
|
Glaucoma Stage
Moderate
|
4 Eyes
n=38 Eyes
|
5 Eyes
n=40 Eyes
|
9 Eyes
n=78 Eyes
|
|
Glaucoma Stage
Severe
|
31 Eyes
n=38 Eyes
|
28 Eyes
n=40 Eyes
|
59 Eyes
n=78 Eyes
|
|
Glaucoma Stage
Indeterminate
|
3 Eyes
n=38 Eyes
|
6 Eyes
n=40 Eyes
|
9 Eyes
n=78 Eyes
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24Population: A participant might contribute one eye to the Baerveldt arm and one eye to the ClearPath arm, meaning they're represented in both groups - but each eye (unit) still only belongs to one.
Mean IOP in each treatment group at the above time points
Outcome measures
| Measure |
Baerveldt 350
n=38 Eyes
The patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
|
Ahmed ClearPath 250
n=40 Eyes
The patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
|
|---|---|---|
|
Intraocular Pressure (IOP)
Baseline
|
22.58 mmHg
Standard Deviation 8.62
|
20.95 mmHg
Standard Deviation 7.00
|
|
Intraocular Pressure (IOP)
Month 1
|
15.0 mmHg
Standard Deviation 4.8
|
15.1 mmHg
Standard Deviation 4.8
|
|
Intraocular Pressure (IOP)
Month 3
|
11.7 mmHg
Standard Deviation 4.7
|
12.1 mmHg
Standard Deviation 4.3
|
|
Intraocular Pressure (IOP)
Month 6
|
11.3 mmHg
Standard Deviation 4.3
|
12.2 mmHg
Standard Deviation 5.3
|
|
Intraocular Pressure (IOP)
Month 12
|
10.0 mmHg
Standard Deviation 3.7
|
12.0 mmHg
Standard Deviation 4.4
|
|
Intraocular Pressure (IOP)
Month 24
|
10.9 mmHg
Standard Deviation 4.0
|
13.6 mmHg
Standard Deviation 3.7
|
Adverse Events
Baerveldt 350
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Ahmed ClearPath 250
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Baerveldt 350
n=38 participants at risk
The patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
|
Ahmed ClearPath 250
n=40 participants at risk
The patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction/Cardiac Arrest (heart attack)*
|
2.6%
1/38 • 24 months
Serious adverse events included death, life-threatening events, hospitalization, significant or permanent vision loss. Events were assessed at each follow-up and recorded from medical records. All implanted eyes were included in the safety analysis and reported per eye.
|
2.5%
1/40 • 24 months
Serious adverse events included death, life-threatening events, hospitalization, significant or permanent vision loss. Events were assessed at each follow-up and recorded from medical records. All implanted eyes were included in the safety analysis and reported per eye.
|
Other adverse events
| Measure |
Baerveldt 350
n=38 participants at risk
The patients in this arm will receive a Baerveldt 350 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
|
Ahmed ClearPath 250
n=40 participants at risk
The patients in this arm will receive an Ahmed ClearPath 250 tube shunt implantation for the treatment of their severe uncontrolled glaucoma.
Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation: Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
|
|---|---|---|
|
Surgical and medical procedures
Surgical failure
|
15.8%
6/38 • 24 months
Serious adverse events included death, life-threatening events, hospitalization, significant or permanent vision loss. Events were assessed at each follow-up and recorded from medical records. All implanted eyes were included in the safety analysis and reported per eye.
|
12.5%
5/40 • 24 months
Serious adverse events included death, life-threatening events, hospitalization, significant or permanent vision loss. Events were assessed at each follow-up and recorded from medical records. All implanted eyes were included in the safety analysis and reported per eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place