Glaucoma
Conditions
Keywords
Baerveldt 350 implant, Ahmed ClearPath implant
Brief 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.
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure (IOP) | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 |
| Number of Participants Who Experienced a Complication | Up to Year 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Humphrey Visual Field (HVF) | Baseline and Year 1 | 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. |
| Best Corrected Visual Acuity (BCVA) | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | — |
| Change in Retinal Nerve Fiber Layer (RNFL) | Baseline and Year 1 | 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. |
| Change in Thickness of the Cornea as Measured by Pachymetry | Baseline and Year 1 | Pachymetry is an ophthalmological test that measures the thickness of the cornea. |
| Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Motility Exam (9 Gaze Photos) | Baseline and Year 1 | — |
| Quality of Life, as Measured by Glaucoma Utility Index | Year 1 | — |
| Change in Self-report Dysesthesia Scale Questionnaire | Baseline and Year 1 | — |
| Change in Motility Exam (Hess Screen Test) | Baseline and Year 1 | If patient is binocular |
| Change in Motility Exam (Worth 4-dot) | Baseline and Year 1 | If patient is binocular |
| Change in Motility Exam (Stereo Test) | Baseline and Year 1 | If patient is binocular |
| Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire | Year 1 | — |
| Quality of Life, as Measured by Glaucoma Symptom Scale | Year 1 | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Duke Eye Center (Durham, NC, USA) and its satellite locations from December 2020 to June 2023.
Participants by arm
| Arm | Count |
|---|---|
| Baerveldt 350 Implant Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant. | 37 |
| Ahmed ClearPath 350 Implant Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device. | 39 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Ahmed ClearPath 350 Implant | Baerveldt 350 Implant | Total |
|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 11.8 | 71.2 years STANDARD_DEVIATION 9.9 | 70.4 years STANDARD_DEVIATION 10.9 |
| Race/Ethnicity, Customized Race Black | 27 Participants | 24 Participants | 51 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 11 Participants | 13 Participants | 24 Participants |
| Region of Enrollment United States | 39 Participants | 37 Participants | 76 Participants |
| Sex: Female, Male Female | 15 Participants | 22 Participants | 37 Participants |
| Sex: Female, Male Male | 24 Participants | 15 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 37 | 0 / 39 |
| other Total, other adverse events | 9 / 37 | 8 / 39 |
| serious Total, serious adverse events | 1 / 37 | 0 / 39 |
Outcome results
Primary
Intraocular Pressure (IOP)
Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Baseline | 21.7 mmHg | Standard Deviation 7.1 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Week 1 | 10.7 mmHg | Standard Deviation 5.8 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Month 3 | 16.5 mmHg | Standard Deviation 6.6 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Day 1 | 14.9 mmHg | Standard Deviation 12.1 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Month 6 | 14.0 mmHg | Standard Deviation 4.3 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Week 4 | 16.0 mmHg | Standard Deviation 8.1 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Month 12 | 14.1 mmHg | Standard Deviation 4.3 |
| Baerveldt 350 Implant | Intraocular Pressure (IOP) | Week 6 | 16.2 mmHg | Standard Deviation 9.7 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Month 12 | 11.4 mmHg | Standard Deviation 3.9 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Baseline | 22.4 mmHg | Standard Deviation 6.7 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Day 1 | 12.6 mmHg | Standard Deviation 10.5 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Week 1 | 11.5 mmHg | Standard Deviation 6.5 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Week 4 | 15.6 mmHg | Standard Deviation 9.2 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Week 6 | 12.1 mmHg | Standard Deviation 5.4 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Month 3 | 12.8 mmHg | Standard Deviation 6.5 |
| Ahmed ClearPath 350 Implant | Intraocular Pressure (IOP) | Month 6 | 12.5 mmHg | Standard Deviation 4.5 |
Comparison: Baselinep-value: 0.687t-test, 2 sided
Comparison: Day 1p-value: 0.384t-test, 2 sided
Comparison: Week 1p-value: 0.597t-test, 2 sided
Comparison: Week 4p-value: 0.86t-test, 2 sided
Comparison: Week 6p-value: 0.032t-test, 2 sided
Comparison: Month 3p-value: 0.026t-test, 2 sided
Comparison: Month 6p-value: 0.172t-test, 2 sided
Comparison: Year 1p-value: 0.01t-test, 2 sided
Primary
Number of Participants Who Experienced a Complication
Time frame: Up to Year 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baerveldt 350 Implant | Number of Participants Who Experienced a Complication | 13 Participants |
| Ahmed ClearPath 350 Implant | Number of Participants Who Experienced a Complication | 4 Participants |
Secondary
Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Baseline | 0.40 LogMAR | Standard Deviation 0.53 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Day 1 | 0.71 LogMAR | Standard Deviation 0.66 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Week 1 | 0.65 LogMAR | Standard Deviation 0.68 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Week 4 | 0.45 LogMAR | Standard Deviation 0.5 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Week 6 | 0.49 LogMAR | Standard Deviation 0.68 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Month 3 | 0.44 LogMAR | Standard Deviation 0.68 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Month 6 | 0.46 LogMAR | Standard Deviation 0.68 |
| Baerveldt 350 Implant | Best Corrected Visual Acuity (BCVA) | Year 1 | 0.36 LogMAR | Standard Deviation 0.55 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Year 1 | 0.72 LogMAR | Standard Deviation 0.76 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Baseline | 0.56 LogMAR | Standard Deviation 0.71 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Week 6 | 0.71 LogMAR | Standard Deviation 0.86 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Day 1 | 1.09 LogMAR | Standard Deviation 0.86 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Month 6 | 0.71 LogMAR | Standard Deviation 0.8 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Week 1 | 1.03 LogMAR | Standard Deviation 0.87 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Month 3 | 0.77 LogMAR | Standard Deviation 0.88 |
| Ahmed ClearPath 350 Implant | Best Corrected Visual Acuity (BCVA) | Week 4 | 0.71 LogMAR | Standard Deviation 0.84 |
Secondary
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
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baerveldt 350 Implant | Change in Humphrey Visual Field (HVF) | 2.81 dB | Standard Deviation 9.58 |
| Ahmed ClearPath 350 Implant | Change in Humphrey Visual Field (HVF) | 4.72 dB | Standard Deviation 13.55 |
p-value: 0.759Wilcoxon rank sum test
Secondary
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
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Baerveldt 350 Implant | Change in Retinal Nerve Fiber Layer (RNFL) | 2.81 µm | Standard Deviation 9.58 |
| Ahmed ClearPath 350 Implant | Change in Retinal Nerve Fiber Layer (RNFL) | 4.72 µm | Standard Deviation 13.55 |
p-value: 0.833Wilcoxon rank sum test
Secondary
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
Population: Participants with data collected at both timepoints.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Baerveldt 350 Implant | Change in Thickness of the Cornea as Measured by Pachymetry | 12.18 µm | Standard Deviation 25.86 |
| Ahmed ClearPath 350 Implant | Change in Thickness of the Cornea as Measured by Pachymetry | 25.96 µm | Standard Deviation 57.79 |
p-value: 0.603Wilcoxon rank sum test
Secondary
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
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Baseline | 2.7 medications | Standard Deviation 1.1 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Day 1 | 0.6 medications | Standard Deviation 0.8 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Week 1 | 0.8 medications | Standard Deviation 1.2 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Week 4 | 1.1 medications | Standard Deviation 1.3 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Week 6 | 1.4 medications | Standard Deviation 1.3 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Month 3 | 1.5 medications | Standard Deviation 1.2 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Month 6 | 2.0 medications | Standard Deviation 1.3 |
| Baerveldt 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Month 12 | 2.3 medications | Standard Deviation 1.2 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Month 12 | 1.6 medications | Standard Deviation 1.5 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Baseline | 2.7 medications | Standard Deviation 1.5 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Week 6 | 1.1 medications | Standard Deviation 1.3 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Day 1 | 0.7 medications | Standard Deviation 1.2 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Month 6 | 1.7 medications | Standard Deviation 1.4 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Week 1 | 0.9 medications | Standard Deviation 1.4 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Month 3 | 1.4 medications | Standard Deviation 1.3 |
| Ahmed ClearPath 350 Implant | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Week 4 | 1.2 medications | Standard Deviation 1.5 |
Other Pre-specified
Change in Motility Exam (9 Gaze Photos)
Time frame: Baseline and Year 1
Other Pre-specified
Change in Motility Exam (Hess Screen Test)
If patient is binocular
Time frame: Baseline and Year 1
Other Pre-specified
Change in Motility Exam (Stereo Test)
If patient is binocular
Time frame: Baseline and Year 1
Other Pre-specified
Change in Motility Exam (Worth 4-dot)
If patient is binocular
Time frame: Baseline and Year 1
Other Pre-specified
Change in Self-report Dysesthesia Scale Questionnaire
Time frame: Baseline and Year 1
Other Pre-specified
Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire
Time frame: Year 1
Other Pre-specified
Quality of Life, as Measured by Glaucoma Symptom Scale
Time frame: Year 1
Other Pre-specified
Quality of Life, as Measured by Glaucoma Utility Index
Time frame: Year 1