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CompletedNCT04468633Updated Sep 5, 2024Results posted

The Baerveldt Versus ClearPath Comparison Study

An interventional study of Baerveldt 350 implant and Ahmed ClearPath 350 implant in Glaucoma, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-05.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.

02

Conditions studied

  • Glaucoma

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Keywords

  • Baerveldt 350 implant
  • Ahmed ClearPath implant
03

In context

Glaucoma

1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.

This study's enrollment of 76 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Browse Duke University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men or women with age at screening ≥ 18 years and ≤ 90 years
  • Inadequately controlled glaucoma
  • Valve-less aqueous shunt as the planned surgical procedure
  • Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
  • Primary tubes included
  • Investigators to recruit consecutively all eligible patients from their clinics.
  • Superotemporal or inferonasal placement of the tube
  • Capable and willing to provide consent

Exclusion criteria

Exclusion Criteria:

  • NLP
  • Unable/unwilling to provide informed consent
  • Unavailable for regular follow up
  • Previous cyclodestructive procedure
  • Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
  • Presence of silicone oil
  • Vitreous in the anterior chamber sufficient to require a vitrectomy
  • Uveitic glaucoma
  • Neovascular glaucoma
  • Nanophthalmos
  • Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
  • Procedure combined with other surgery
  • Any abnormality other than glaucoma in the study eye that could affect tonometry.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    Baerveldt 350 implant

    Device: Baerveldt 350 implant

  • Active comparator
    Ahmed ClearPath 350 implant

    Device: Ahmed ClearPath 350 implant

Interventions

  • DeviceBaerveldt 350 implant

    The Baerveldt implant is an FDA-approved silicone, non-valved implant.

  • DeviceAhmed ClearPath 350 implant

    The Ahmed ClearPath is a non-valved glaucoma drainage device.

06

What researchers measure

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  2. Number of Participants Who Experienced a Complication

    Time frame: Up to Year 1

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  2. Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)

    Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  3. Change in Humphrey Visual Field (HVF)

    The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.

    Time frame: Baseline and Year 1

  4. Change in Thickness of the Cornea as Measured by Pachymetry

    Pachymetry is an ophthalmological test that measures the thickness of the cornea.

    Time frame: Baseline and Year 1

  5. Change in Retinal Nerve Fiber Layer (RNFL)

    The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.

    Time frame: Baseline and Year 1

Other outcomes

  1. Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire

    Time frame: Year 1

  2. Quality of Life, as Measured by Glaucoma Symptom Scale

    Time frame: Year 1

  3. Quality of Life, as Measured by Glaucoma Utility Index

    Time frame: Year 1

  4. Change in Self-report Dysesthesia Scale Questionnaire

    Time frame: Baseline and Year 1

  5. Change in Motility Exam (Hess Screen Test)

    If patient is binocular

    Time frame: Baseline and Year 1

  6. Change in Motility Exam (Worth 4-dot)

    If patient is binocular

    Time frame: Baseline and Year 1

  7. Change in Motility Exam (Stereo Test)

    If patient is binocular

    Time frame: Baseline and Year 1

  8. Change in Motility Exam (9 Gaze Photos)

    Time frame: Baseline and Year 1

07

Results

Posted Sep 5, 2024

Participant flow

Participants were recruited from the Duke Eye Center (Durham, NC, USA) and its satellite locations from December 2020 to June 2023.

Participant flow — Overall Study
MilestoneBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Started3739
Completed3339
Not completed40
Withdrew: Withdrawal by subject40

Outcome measures

PrimaryIntraocular Pressure (IOP)
Time frame:
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Reported as:
Mean · mmHg
Intraocular Pressure (IOP)
mmHgBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Baseline21.7 ± 7.122.4 ± 6.7
Day 114.9 ± 12.112.6 ± 10.5
Week 110.7 ± 5.811.5 ± 6.5
Week 416.0 ± 8.115.6 ± 9.2
Week 616.2 ± 9.712.1 ± 5.4
Month 316.5 ± 6.612.8 ± 6.5
Month 614.0 ± 4.312.5 ± 4.5
Month 1214.1 ± 4.311.4 ± 3.9
Statistical analysis
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.687
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.384
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.597
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.860
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.032
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.026
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.172
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · t-test, 2 sided · p = 0.010
PrimaryNumber of Participants Who Experienced a Complication
Time frame:
Up to Year 1
Reported as:
Count of participants · Participants
Number of Participants Who Experienced a Complication
ParticipantsBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Number of Participants Who Experienced a Complication134
SecondaryBest Corrected Visual Acuity (BCVA)
Time frame:
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Reported as:
Mean · LogMAR
Best Corrected Visual Acuity (BCVA)
LogMARBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Baseline0.40 ± 0.530.56 ± 0.71
Day 10.71 ± 0.661.09 ± 0.86
Week 10.65 ± 0.681.03 ± 0.87
Week 40.45 ± 0.500.71 ± 0.84
Week 60.49 ± 0.680.71 ± 0.86
Month 30.44 ± 0.680.77 ± 0.88
Month 60.46 ± 0.680.71 ± 0.80
Year 10.36 ± 0.550.72 ± 0.76
SecondaryNumber of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Time frame:
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Reported as:
Mean · medications
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
medicationsBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Baseline2.7 ± 1.12.7 ± 1.5
Day 10.6 ± 0.80.7 ± 1.2
Week 10.8 ± 1.20.9 ± 1.4
Week 41.1 ± 1.31.2 ± 1.5
Week 61.4 ± 1.31.1 ± 1.3
Month 31.5 ± 1.21.4 ± 1.3
Month 62.0 ± 1.31.7 ± 1.4
Month 122.3 ± 1.21.6 ± 1.5
SecondaryChange in Humphrey Visual Field (HVF)

The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.

Time frame:
Baseline and Year 1
Reported as:
Mean · dB
Change in Humphrey Visual Field (HVF)
dBBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Change in Humphrey Visual Field (HVF)2.81 ± 9.584.72 ± 13.55
Statistical analysis
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · Wilcoxon rank sum test · p = 0.759
SecondaryChange in Thickness of the Cornea as Measured by Pachymetry

Pachymetry is an ophthalmological test that measures the thickness of the cornea.

Time frame:
Baseline and Year 1
Reported as:
Median · µm
Change in Thickness of the Cornea as Measured by Pachymetry
µmBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Change in Thickness of the Cornea as Measured by Pachymetry12.18 ± 25.8625.96 ± 57.79
Statistical analysis
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · Wilcoxon rank sum test · p = 0.603
Other pre-specifiedQuality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire
Time frame:
Year 1

Results for this outcome have not been posted.

Other pre-specifiedQuality of Life, as Measured by Glaucoma Symptom Scale
Time frame:
Year 1

Results for this outcome have not been posted.

Other pre-specifiedQuality of Life, as Measured by Glaucoma Utility Index
Time frame:
Year 1

Results for this outcome have not been posted.

Other pre-specifiedChange in Self-report Dysesthesia Scale Questionnaire
Time frame:
Baseline and Year 1

Results for this outcome have not been posted.

Other pre-specifiedChange in Motility Exam (Hess Screen Test)

If patient is binocular

Time frame:
Baseline and Year 1

Results for this outcome have not been posted.

Other pre-specifiedChange in Motility Exam (Worth 4-dot)

If patient is binocular

Time frame:
Baseline and Year 1

Results for this outcome have not been posted.

Other pre-specifiedChange in Motility Exam (Stereo Test)

If patient is binocular

Time frame:
Baseline and Year 1

Results for this outcome have not been posted.

Other pre-specifiedChange in Motility Exam (9 Gaze Photos)
Time frame:
Baseline and Year 1

Results for this outcome have not been posted.

SecondaryChange in Retinal Nerve Fiber Layer (RNFL)

The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.

Time frame:
Baseline and Year 1
Reported as:
Median · µm
Change in Retinal Nerve Fiber Layer (RNFL)
µmBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Change in Retinal Nerve Fiber Layer (RNFL)2.81 ± 9.584.72 ± 13.55
Statistical analysis
  • Baerveldt 350 Implant vs Ahmed ClearPath 350 Implant · Wilcoxon rank sum test · p = 0.833

Adverse events

Collected over Up to 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Baerveldt 350 Implant1/37 (2.7%)1/37 (2.7%)9/37 (24.3%)
Ahmed ClearPath 350 Implant0/39 (0%)0/39 (0%)8/39 (20.5%)
Most frequent serious events
Most frequent serious events
EventBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Myocardial infarction (heart attack)Cardiac disorders1/370/39
Most frequent other events
Most frequent other events
EventBaerveldt 350 ImplantAhmed ClearPath 350 Implant
Surgical failureSurgical and medical procedures9/378/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)Baerveldt 350 ImplantAhmed ClearPath 350 ImplantTotal
Mean71.2 ± 9.969.6 ± 11.870.4 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Baerveldt 350 ImplantAhmed ClearPath 350 ImplantTotal
Female221537
Male152439
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Baerveldt 350 ImplantAhmed ClearPath 350 ImplantTotal
Race — White131124
Race — Black242751
Race — Other011
Region of Enrollment
Region of Enrollment(Participants)Baerveldt 350 ImplantAhmed ClearPath 350 ImplantTotal
United States373976
08

Study locations

1 site
  • Duke Eye Center
    Durham, North Carolina 27705, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 10, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2020 to primary completion in Jun 2023, 30 months.

Results were first posted in Sep 2024, 1 year 2 months after primary completion.

Of 272 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 55. This study's 30 months is close to that.

Counting every sponsor, half of 355 studies reached it within 29 months; a quarter within 15 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2020
First posted
Jul 13, 2020
StartActual
Dec 17, 2020
Primary completionActual
Jun 29, 2023
CompletionActual
Jun 29, 2023
Results first posted
Sep 5, 2024
Last update
Sep 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04468633
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 13, 2020
Start date
Dec 17, 2020
Primary completion
Jun 29, 2023
Completion
Jun 29, 2023
Results posted
Sep 5, 2024
Last update
Sep 5, 2024

Study contacts

Leon Herndon, MD
principal investigator · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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