Glaucoma
Conditions
Keywords
Glaucoma, Baerveldt 350, Ahmed ClearPath 250
Brief summary
To compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 250 tube shunts in lowering IOP in glaucoma patients.
Detailed description
Tube shunt implantation is a common type of surgery considered standard of care for treating significant potentially-blinding glaucoma where medical and laser treatment, and previous surgeries, have failed to control intra-ocular pressure (IOP) sufficiently to stop glaucoma progression towards blindness. Since a larger plate tube (e.g., Baerveldt 350) is more difficult to implant requiring longer surgical time and intraoperative ocular muscle manipulation with possible patient discomfort, a smaller plate tube shunt (e.g., Ahmed ClearPath 250) requiring shorter surgical time and no ocular muscle manipulation may have an advantage if the long term surgical outcomes were the same. However, the literature is lacking regarding the effect of the tube plate size on the final outcomes of tube shunt implantation. Most published comparisons are between totally different types of tube shunts regardless of plate size, often made of different materials, often comparing valved vs. non-valved tube shunts,combining different plate sizes in the same study groups,5 mixing tubes with or without combined cataract surgery in the same study groups, or comparing surgeries performed by several surgeons utilizing different surgical methods. Further, all these studies utilize tubes implanted into the anterior chamber (AC) thus increasing the risk of corneal failure, with no comparisons at all between tube shunts implanted through the ciliary sulcus of the eye designed to reduce the risk of corneal failure. Our Principle Investigator (AW) is specializing and well-published in this type of tube shunt implantation. This prospective randomized trial is designed to resolve all these confusing factors in the literature and finally provide the answer of whether tube plate size has an effect on the final outcomes of tube shunt implantation by performing a "clean" study that would isolate the effect of tube plate size on long term outcomes. To achieve this goal our study will utilize two non-valved tube shunts with a different plate size (350 vs. 250 mm2) made of identical materials, in eyes that have already had cataract surgery, and all performed by the same surgeon (AW) through the ciliary sulcus.
Interventions
DEVICEBaerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation
Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All patients will sign a consent form indicating they will be randomly receiving one of the 2 tube shunt models. It would be impossible to mask the patient or care provider to the type of tube shunt a patient received. The patients cannot bias the clinical data recorded on their follow up exams. All data will be recorded objectively. The outcome assessor will be masked to the type of shunt used.
Intervention model description
Comparison between 2 groups of patients requiring tube shunt implantation to treat their severe uncontrolled glaucoma. One group will receive a unilateral Baerveldt 350 tube shunt and the other a unilateral Ahmed ClearPath 250 tube shunt. The patients will be sequentially randomized into one of these tube shunts.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Significant uncontrolled glaucoma despite medical, laser or previous surgical therapy that requires tube shunt implantation as standard-of-care to stabilize the glaucoma and preserve vision. * Pseudophakia * Patients who are willing to participate and are able to understand and sign the study consent form. * Age ≥18 years.
Exclusion criteria
* Phakic eyes (no previous cataract surgery). * Aphakic eyes (status post previous cataract removal but without a lens implant). * Age \<18 years. * Women of child-bearing age. * Patients unable to comprehend and sign the study consent form. * Women who are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 | Mean IOP in each treatment group at the above time points |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAsher Weiner, MD
The Ross Eye Institute
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Eyes |
| Age, Categorical >=65 years | 62 Eyes |
| Age, Categorical Between 18 and 65 years | 16 Eyes |
| Glaucoma Stage Indeterminate | 9 Eyes |
| Glaucoma Stage Mild | 1 Eyes |
| Glaucoma Stage Moderate | 9 Eyes |
| Glaucoma Stage Severe | 28 Eyes |
| Mean Preop IOP (mmHg) | 20.32 mmHg STANDARD_DEVIATION 6.67 |
| Race/Ethnicity, Customized Black | 10 Participants |
| Race/Ethnicity, Customized Unspecified | 26 Participants |
| Race/Ethnicity, Customized Unspecified (Not Hispanic or Latino) | 3 Participants |
| Race/Ethnicity, Customized White | 31 Participants |
| Sex: Female, Male Female | 36 Eyes |
| Sex: Female, Male Male | 42 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 38 | 1 / 40 |
| other Total, other adverse events | 6 / 38 | 5 / 40 |
| serious Total, serious adverse events | 1 / 38 | 1 / 40 |
Outcome results
None listed