CataractAurosleekNCT01763593
Safety and Surgical Performance Study of Aurosleek Surgical Blades
An observational study of Cataract, run by Aurolab at 1 site in India.
Trial summary
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2013to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cataract surgery would be included in this observational study
Who may be able to join
- Senile cataract
- Willing to give written informed consent
- Ability to follow study instructions and likely to complete required visits.
Who cannot join
- Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
- Traumatic cataract
- Uveitis and Complicated cataract
- One eyed patients
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020
Neeraj Kumar Agrawal, MS, 04524356100 ext. 181, agrawalneeraj84@gmail.com
About this study
Official title: A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.
Read the 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.
- Conditions
- Cataract
- Keywords
- Patients having cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aurosleek blades | Patients having cataract will undergo surgery by using Aurosleek blades |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Post operative complications
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeraj Kumar Agrawal, MS, Principal investigator, Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763593
- Sponsor's protocol ID
- AUROSLEEK/CIP/001/2012
- Acronym
- Aurosleek
- Status last verified
- Apr 2013
- First submitted
- 25 Dec 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients
- ClinicalTrials.gov ID
- NCT01763593
- Acronym / sponsor ID
- Aurosleek / AUROSLEEK/CIP/001/2012
- Conditions
- Cataract
- Keywords
- Patients having cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aurosleek blades | – | –Patients having cataract will undergo surgery by using Aurosleek blades |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cataract surgery would be included in this observational study
Key inclusion criteria (3 listed)
- Senile cataract
- Willing to give written informed consent
- Ability to follow study instructions and likely to complete required visits.
Key exclusion criteria (4 listed)
- Intraoperative complication including Posterior Capsular Rent and Zonular dialysis
- Traumatic cataract
- Uveitis and Complicated cataract
- One eyed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Post operative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neeraj Kumar Agrawal, MS principal investigator
Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Aurolab at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karthikumar S, M.Pharm (04523096100 ext. 228, crd@aurolab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physioclinical Characters (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.