NCT01763593

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

December 25, 2012

Last Update Submit

April 29, 2013

Conditions

Cataract

Keywords

Patients having cataract

Outcome Measures

Primary Outcomes (1)

  • Physioclinical Characters

    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 Outcomes (1)

  • Post operative complications

    30 days

Study Arms (1)

Aurosleek blades

Patients having cataract will undergo surgery by using Aurosleek blades

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cataract surgery would be included in this observational study

You may qualify if:

  • Senile cataract
  • Willing to give written informed consent
  • Ability to follow study instructions and likely to complete required visits.

You may not qualify if:

  • Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
  • Traumatic cataract
  • Uveitis and Complicated cataract
  • One eyed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Neeraj Kumar Agrawal, MS

    Medical Officer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karthikumar S, M.Pharm

CONTACT

04523096100crd@aurolab.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2012

First Posted

January 9, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

IN(1)