Safety and Surgical Performance Study of Aurosleek Surgical Blades

• Conditions: Cataract

• Registration Number: NCT01763593
• Lead Sponsor: Aurolab

Brief Summary

To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-12-25
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Study Start: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-04-30
• Primary Completion: 2013-05
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Senile cataract
• Willing to give written informed consent
• Ability to follow study instructions and likely to complete required visits.

Exclusion Criteria

• Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
• Traumatic cataract
• Uveitis and Complicated cataract
• One eyed patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physioclinical Characters	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Post operative complications	30 days	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.

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamilnadu, India