Glaucoma
Conditions
Keywords
Refractory Glaucoma, Intractable Glaucoma, Primary Open Angle Glaucoma, Neovascular Glaucoma
Brief summary
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
Detailed description
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.
Interventions
DEVICESilicone plate Ahmed Glaucoma Valve (Model FP7)
This intervention is conducted as a surgical intervention.
DEVICEPorous Plate Ahmed Glaucoma Valve (Model M4)
This intervention is conducted as a surgical intervention.
Sponsors
New World Medical, Inc.
Peter Netland, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of any race ≥ 18 years and ≤ 80 years of age. * Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy. * Elevated intraocular pressure \> 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure. * Subject is a candidate for surgery in the study eye with a glaucoma drainage device. * Subject is willing and able to sign the informed consent.
Exclusion criteria
* Diagnosis of silicone oil endotamponade induced glaucoma in the study eye. * History of prior drainage implant surgery in the study eye. * History of cyclophotocoagulation of the study eye. * Pregnancy. * Prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure | 12 months | The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Glaucoma Medications | 12 months | The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months. |
| Surgical Success | 12 months | Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silicone Plate Ahmed Glaucoma Valve Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention. | 26 |
| Porous Plate Ahmed Glaucoma Valve Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention. | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Silicone Plate Ahmed Glaucoma Valve | Porous Plate Ahmed Glaucoma Valve | Total |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 11.2 | 67.0 years STANDARD_DEVIATION 10.1 | 67.3 years STANDARD_DEVIATION 10.7 |
| Pre-operative intraocular pressure | 29.91 mmHg STANDARD_DEVIATION 6.55 | 33.79 mmHg STANDARD_DEVIATION 10.54 | 31.85 mmHg STANDARD_DEVIATION 8.55 |
| Race/Ethnicity, Customized Ethnicity African American | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 14 Participants | 14 Participants | 28 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed Race | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Brazil | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment Canada | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 17 Participants | 21 Participants | 38 Participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 21 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 13 / 26 | 15 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Change in Intraocular Pressure
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silicone Plate Ahmed Glaucoma Valve | Change in Intraocular Pressure | 13.60 mmHg | Standard Deviation 4.69 |
| Porous Plate Ahmed Glaucoma Valve | Change in Intraocular Pressure | 17.94 mmHg | Standard Deviation 10.95 |
Secondary
Anti-Glaucoma Medications
The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silicone Plate Ahmed Glaucoma Valve | Anti-Glaucoma Medications | 1.64 glaucoma medications | Standard Deviation 1.4 |
| Porous Plate Ahmed Glaucoma Valve | Anti-Glaucoma Medications | 1.89 glaucoma medications | Standard Deviation 1.54 |
Secondary
Surgical Success
Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silicone Plate Ahmed Glaucoma Valve | Surgical Success | 23 surgical success |
| Porous Plate Ahmed Glaucoma Valve | Surgical Success | 14 surgical success |