Safety and Surgical Performance Study of Aurosleek Surgical Blades

A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01763593

Acronym

Aurosleek

Enrollment

Registered

2013-01-09

Start date

2013-03-31

Completion date

2013-06-30

Last updated

2013-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Patients having cataract

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Physioclinical Characters	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

Measure	Time frame	Description
Post operative complications	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.

Countries

India

Contacts

Primary ContactKarthikumar S, M.Pharm

crd@aurolab.com04523096100

Outcome results