Safety and Surgical Performance Study of Aurosleek Surgical Blades

Aurolab

Status: Unknown

Conditions: Cataract

Study type: Observational

Funder types: Other

Identifiers

NCT01763593

AUROSLEEK/CIP/001/2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

35 participants in 1 patient group

Aurosleek blades

Description:

Patients having cataract will undergo surgery by using Aurosleek blades