Safety and Surgical Performance Study of Aurosleek Surgical Blades

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Aurolab
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01763593
First received: December 25, 2012
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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


Condition
Cataract

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 ] [ 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.



Secondary Outcome Measures:
  • 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.



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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing cataract surgery would be included in this observational study

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763593

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

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

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01763593     History of Changes
Other Study ID Numbers: AUROSLEEK/CIP/001/2012
Study First Received: December 25, 2012
Last Updated: April 29, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Aurolab:
Patients having cataract

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 29, 2014