CataractNCT01396629
Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
An observational study of Cataract, run by Aurolab at 1 site in India.
Trial summary
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Cataract
- What is being tested?
- cartridge
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Oct 2012
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between 40-60
Who may be able to join
- Age 40 to 60
- Senile cataract
- Nuclear Sclerosis grade I and grade II
Who cannot join
- Inherent zonular weakness
- Shallow anterior chamber
- PXF
- Traumatic cataract
- Uveitis and Complicated cataract
- Dense PSCC and PPC
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.
Read the detailed description
Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.
- Conditions
- Cataract
- Being tested
- cartridge
- Keywords
- cartridge IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cartridgeProcedure or surgery
IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| single group | the intra ocular lenses will be loaded in the cartridge. Receives: Procedure: cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra operative complication
to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1
Measured: post operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionOct 2012
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
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Haripriya Aravind, MBBS., MS.,, Principal investigator, HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396629
- Sponsor's protocol ID
- 8PN1011155
- Status last verified
- Nov 2012
- First submitted
- 14 Jul 2011
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
- ClinicalTrials.gov ID
- NCT01396629
- Acronym / sponsor ID
- 8PN1011155
- Conditions
- Cataract
- Keywords
- cartridge IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Jul 2011 (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.
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.
Detailed description
Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | – | Procedure: cartridgethe intra ocular lenses will be loaded in the cartridge. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between 40-60
Key inclusion criteria (3 listed)
- Age 40 to 60
- Senile cataract
- Nuclear Sclerosis grade I and grade II
Key exclusion criteria (6 listed)
- Inherent zonular weakness
- Shallow anterior chamber
- PXF
- Traumatic cataract
- Uveitis and Complicated cataract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cartridgeIOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery | Procedure or surgery | single group |
Primary outcome
intra operative complication
Time frame: post operative day 1
to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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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.
Dr. Haripriya Aravind, MBBS., MS., principal investigator
HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai
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 6 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: finished, as of the sponsor's last update on 16 Nov 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra operative complication (time frame: post operative day 1). 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 16 Nov 2012.