AstigmatismPhase 4TORICIOLNCT01396616
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
A Phase 4 study testing Experimental - Toric Intraocular lenses in people with Astigmatism, run by Aurolab at 1 site in India.
Trial summary
The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- Experimental - Toric Intraocular lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Jun 2013
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 65
- Senile cataract
- Posterior Sub Capsular Cataract (PSCC)
- Astigmatism 1.25 D or more
- Residence within 100 kms of Madurai
Who cannot join
- Traumatic \& Complicated cataract
- Poor mydriasis
- Amblyopia
- Severe Pseudo exfoliation (PXF)
- Dense posterior polar cataract (PPC)
- One eyed patients
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- Uveitis
- Corneal pathology / Scar
- Retinal Pathology contributing to visual loss
- Intraoperative complication like PC rupture, Zonular dialysis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020
Dr. Haripriya Aravind, MBBS., MS, +91 452 4356100 ext. 161, drharipriya@aravind.org
Mrs. Kamatchi Kannan, BA, +91 452 4356100 ext. 364, clinicaltrials@aravind.org
About this study
The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.
Read the detailed description
Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.
Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.
- Conditions
- Astigmatism
- Being tested
- Experimental - Toric Intraocular lenses
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - Toric Intraocular lensesDevice
Toric Intraocular Lenses will be implenated with cataract patients having astigmatism
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | The enrolled subject will be implanted with Toric IOL manufactured by AuroLab Receives: Device: Experimental - Toric Intraocular lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
vision improvement
The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively
Measured: 150 days
Secondary outcomes (1)
Refractive error correction
To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively
Measured: 150 days
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 startAug 2011
- 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 AstigmatismStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,, Principal investigator, HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396616
- Sponsor's protocol ID
- 1PN1011037
- Acronym
- TORICIOL
- Status last verified
- Jul 2011
- First submitted
- 14 Jul 2011
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
- ClinicalTrials.gov ID
- NCT01396616
- Acronym / sponsor ID
- TORICIOL / 1PN1011037
- Conditions
- Astigmatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- 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 purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.
Detailed description
Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.
Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Experimental - Toric Intraocular lensesThe enrolled subject will be implanted with Toric IOL manufactured by AuroLab |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 to 65
- Senile cataract
- Posterior Sub Capsular Cataract (PSCC)
- Astigmatism 1.25 D or more
- Residence within 100 kms of Madurai
Key exclusion criteria (10 listed)
- Traumatic \& Complicated cataract
- Poor mydriasis
- Amblyopia
- Severe Pseudo exfoliation (PXF)
- Dense posterior polar cataract (PPC)
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 |
|---|---|---|
| Experimental - Toric Intraocular lensesToric Intraocular Lenses will be implenated with cataract patients having astigmatism | Device | Single Arm |
Primary outcome
vision improvement
Time frame: 150 days
The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively
1 secondary outcome
Refractive error correction
Time frame: 150 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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.
Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS., principal investigator
HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental - Toric Intraocular lenses in people with Astigmatism, 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 5 inclusion and 10 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 8 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dr. Haripriya Aravind, MBBS., MS., (+91 452 4356100 ext. 161, haripriya@aravind.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vision improvement (time frame: 150 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 8 Jan 2013.