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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Aurolab.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: January 9, 2013
Last Update Posted: April 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.


Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 35
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)
Aurosleek blades
Patients having cataract will undergo surgery by using Aurosleek blades

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cataract surgery would be included in this observational study

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01763593

Contact: Karthikumar S, M.Pharm 04523096100 ext 228 crd@aurolab.com

Aravind Eye Hospital Recruiting
Madurai, Tamilnadu, India, 625020
Contact: Neeraj Kumar Agrawal, MS    04524356100 ext 181    agrawalneeraj84@gmail.com   
Sponsors and Collaborators
Principal Investigator: Neeraj Kumar Agrawal, MS Medical Officer
  More Information

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01763593     History of Changes
Other Study ID Numbers: AUROSLEEK/CIP/001/2012
First Submitted: December 25, 2012
First Posted: January 9, 2013
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Aurolab:
Patients having cataract

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases