MedDataX Logo

Safety and Surgical Performance Study of Aurosleek Surgical Blades

NCT ID: NCT01763593

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Patients having cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aurosleek blades

Patients having cataract will undergo surgery by using Aurosleek blades

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aurolab

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neeraj Kumar Agrawal, MS

Role: PRINCIPAL_INVESTIGATOR

Medical Officer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aravind Eye Hospital

Madurai, Tamil Nadu, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karthikumar S, M.Pharm

Role: CONTACT

Phone: 04523096100

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Neeraj Kumar Agrawal, MS

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AUROSLEEK/CIP/001/2012

Identifier Type: -

Identifier Source: org_study_id