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
Information provided by (Responsible Party):
First received: December 25, 2012
Last updated: April 29, 2013
Last verified: April 2013
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.
||Observational Model: Case-Only
Time Perspective: Prospective
||A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Patients having cataract will undergo surgery by using Aurosleek blades
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing cataract surgery would be included in this observational study
- Senile cataract
- Willing to give written informed consent
- Ability to follow study instructions and likely to complete required visits.
- Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
- Traumatic cataract
- Uveitis and Complicated cataract
- One eyed patients
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01763593
|Aravind Eye Hospital
|Madurai, Tamilnadu, India, 625020 |
||Neeraj Kumar Agrawal, MS
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 25, 2012
||April 29, 2013
Keywords provided by Aurolab:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 19, 2017