Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04542616
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2020-08-27
Brief Title:
Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
Outcomes Comparison Between Baerveldt 350 and Ahmed ClearPath 250 Tube Shunts for the Treatment of Glaucoma
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B350vsCP250
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 eg 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 eg 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 shuntscombining different plate sizes in the same study groups5 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
Since a larger plate tube eg 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 eg 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 shuntscombining different plate sizes in the same study groups5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None