Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351429
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2006-07-11
Brief Title:
Study of PGA Suture in Ophthalmology
Sponsor:
Aurolab
Organization:
Aurolab
Study Overview
Official Title:
Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures
Status:
COMPLETED
Status Verified Date:
2009-02
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:
To evaluate the safety and efficacy of polyglycolic acid suture in ophthalmic surgical procedures
Detailed Description:
The sutures are classified into non-absorbable and absorbable sutures Violet braided polyglycolic acid suture is the synthetic absorbable suture used in wound closure in ophthalmology cardiology neurology and plastic reconstructive surgeries In ophthalmology PGA sutures are used in Trabeculectomy Glaucoma Orbit and Oculoplasty Lid and Socket Reconstruction Squint ptosis and retinal detachment surgeries
Glaucoma patients who met the inclusion criteria were recruited for this study Uniform surgery and suturing technique was performed in all patients Trabeculectomy with IOL implantation Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery
Patients were followed up during 1 day 1 month and 3 months post operatively Visual acuity Intraocular Pressure IOP suture characteristics wound integrity inflammation and conjunctival status were examined during each follow up visit
Glaucoma patients who met the inclusion criteria were recruited for this study Uniform surgery and suturing technique was performed in all patients Trabeculectomy with IOL implantation Surgeon assessed suture characteristics during surgery and wound integrity at the end of surgery
Patients were followed up during 1 day 1 month and 3 months post operatively Visual acuity Intraocular Pressure IOP suture characteristics wound integrity inflammation and conjunctival status were examined during each follow up visit
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