Safety and Surgical Performance Study of Aurosleek Surgical Blades (Aurosleek)

April 29, 2013 updated by: Aurolab

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Madurai, Tamilnadu, India, 625020
        • Recruiting
        • Aravind Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cataract surgery would be included in this observational study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Aurosleek blades
Patients having cataract will undergo surgery by using Aurosleek blades

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physioclinical Characters
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative complications
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Investigators

  • Principal Investigator: Neeraj Kumar Agrawal, MS, Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

December 25, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUROSLEEK/CIP/001/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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