Safety and Surgical Performance Study of Aurosleek Surgical Blades

Cataract Clinical Trial

— Aurosleek  

Official title:

A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01763593
• Other study ID #: AUROSLEEK/CIP/001/2012
• Status: Recruiting
• Phase: N/A
• First received: December 25, 2012
• Last updated: April 29, 2013
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Aurolab
• Contact: Karthikumar S, M.Pharm
• Phone: 04523096100
• Email: crd[@]aurolab.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physioclinical Characters	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.	30 days	No
Secondary	Post operative complications	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.	30 days	Yes