Safety and Surgical Performance Study of Aurosleek Surgical Blades
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients|
- Physioclinical Characters [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Assessment of physio-clinical characteristics of surgical blade such as handling of the blade, sharpness and smoothness of blade.
Handling of the surgical blade will be assessed in grades of difficult to handle,easy to handle and very easy to handle intraoperatively. Sharpness and smoothness of the blade will be rated as poor or optimum while performing cataract surgery.
- Post operative complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The frequency and occurrence of post operative complications such as rhexis tear, posterior capsular rupture, severe corneal edema, severe iritis and anterior vitrectomy.
Post operative complications occurrence due to surgical blade will be observed and graded as none or mild or moderate or severe at surgery and post operative 30 days.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Patients having cataract will undergo surgery by using Aurosleek blades
Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763593
|Contact: Karthikumar S, M.Pharm||04523096100 ext firstname.lastname@example.org|
|Aravind Eye Hospital||Recruiting|
|Madurai, Tamilnadu, India, 625020|
|Contact: Neeraj Kumar Agrawal, MS 04524356100 ext 181 email@example.com|
|Principal Investigator:||Neeraj Kumar Agrawal, MS||Medical Officer|