Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05500469
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-08-11
Brief Title:
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber a Randomized Controlled Trial
Sponsor:
Oogziekenhuis Rotterdam
Organization:
Oogziekenhuis Rotterdam
Study Overview
Official Title:
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-12
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:
None
Brief Summary:
Rationale Glaucoma is a group of diseases characterized by progressive neuropathy of the optic nerve associated with visual field loss Current glaucoma management aims to preserve visual function throughout life by reducing the intraocular pressure This can be achieved by medical therapy or by surgical procedures such as implantation of a glaucoma drainage device GDD Conventionally the tube of such a device is positioned in the anterior chamber AC Unfortunately the presence of the tube in the AC may have a significant negative impact on the number of endothelial cells of the cornea and may even lead to corneal decompensation Alternatively the tube can be positioned in the posterior chamber ie behind the iris In this study both procedures will be compared
Objective Primary to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris Secondary to compare efficacy and safety of both procedures
Study design Prospective randomised treatment controlled clinical trial Study population Pseudophakic patients with glaucoma who need a GDD Intervention Implantation of a Paul GDD with its tube anteriorposterior of the iris Main study parametersendpoints Endothelial cell loss of the cornea
Nature and extent of the burden and risks associated with participation benefit and group relatedness At present potential benefits and drawbacks of positioning the Paul tube behind the iris are insufficiently known successful positioning of the tube may require slightly more surgery time and the risk of hyphaema may be higher It is expected that in the long run damage to the corneal endothelium is less Risks of study-related assessments are negligible burden is low extra time is about 35153535 minutes total 2h
Objective Primary to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris Secondary to compare efficacy and safety of both procedures
Study design Prospective randomised treatment controlled clinical trial Study population Pseudophakic patients with glaucoma who need a GDD Intervention Implantation of a Paul GDD with its tube anteriorposterior of the iris Main study parametersendpoints Endothelial cell loss of the cornea
Nature and extent of the burden and risks associated with participation benefit and group relatedness At present potential benefits and drawbacks of positioning the Paul tube behind the iris are insufficiently known successful positioning of the tube may require slightly more surgery time and the risk of hyphaema may be higher It is expected that in the long run damage to the corneal endothelium is less Risks of study-related assessments are negligible burden is low extra time is about 35153535 minutes total 2h
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8130507822 | OTHER | None | None |
| MEC-2022-0364 | OTHER | MEC | None |