Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539637
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 10 Ketorolac 03
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 10 Ketorolac 03
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical trial evaluating Ketorolac levels in vitreous and aqueous humor samples from patients undergoing combined cataract and pars plana vitrectomy surgeries with and without intracameral phenylephrine 10 ketorolac 03 OMIDRIA Patients not receiving intracameral OMIDRIA will receive topical ketorolac prior to cataract surgerypars plana vitrectomy
Detailed Description:
Cataract surgery can result in intra- and postoperative inflammation Various strategies are employed to prevent and combat this inflammatory reaction including preoperative topical NSAIDs intraoperative NSAIDs or steroids and postoperative topical NSAIDs andor steroids The only FDA-approved NSAID for intraoperative use is the ketorolac component of OMIDRIA Rayner Surgical Bellevue WA USA
Animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery
This study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations
Animal studies have assessed the concentration of ketorolac in the vitreous and demonstrated therapeutic levels out to 10 hours postoperatively There is no human data for ketorolac levels in the vitreous following intracameral administration of OMIDRIA at the time of cataract surgery
This study will enroll approximately 10-20 patients undergoing combined cataract surgery immediately followed by pars plana vitrectomy Aqueous and vitreous samples will be taken intraoperatively and sent to an independent lab for analysis of ketorolac concentrations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None