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

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ClinicalTrials.gov Identifier: NCT01763593
Recruitment Status : Unknown
Verified April 2013 by Aurolab.
Recruitment status was:  Recruiting
First Posted : January 9, 2013
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
Aurolab

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

Condition or disease
Cataract

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
Estimated Enrollment : 35 participants
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
Study Start Date : March 2013
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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.




Information from the National Library of Medicine

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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
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

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


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

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

Keywords provided by Aurolab:
Patients having cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases