Study of PGA Suture in Ophthalmology
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|ClinicalTrials.gov Identifier: NCT00351429|
Recruitment Status : Completed
First Posted : July 12, 2006
Last Update Posted : February 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Device: Polyglycolic acid suture||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Safety and Efficacy of Polyglycolic Acid Suture in Ophthalmic Surgical Procedures|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
Device: Polyglycolic acid suture
PGA suture used in Trabeculectomy surgery
Other Name: Aurocryl
- Suture characteristics [ Time Frame: 1 month, 3 months ]
- Bleb characteristics [ Time Frame: 1 month, 3 months ]
- Conjunctival status [ Time Frame: 1 month, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351429
|Aravind Eye Hospital|
|Madurai, Tamil Nadu, India, 625 020|
|Principal Investigator:||Ramaswamy Krishnadas, DO, Dip NB||Aravind Eye Hospital, Madurai|