CataractNCT00925886
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
A study testing Acrysof Toric one-piece intraocular lens in people with Cataract and Astigmatism, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Acrysof Toric one-piece intraocular lens
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2007to Mar 2009
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.
Who cannot join
- Irregular astigmatism,
- Keratoconus,
- Previous Refractive Surgery.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion Para Evitar la Ceguera en Mexico
Mexico City, D.F., 04030
About this study
The purpose of this study is to evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens.
Read the detailed description
Patients with Cataract are treated with phacoemulsification of the lens with an implantation of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an implantation of a toric intraocular lens.
- Conditions
- Cataract, Astigmatism
- Being tested
- Acrysof Toric one-piece intraocular lens
- Keywords
- Astigmatism, Cataract
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrysof Toric one-piece intraocular lensProcedure or surgery
Also called Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC
Cataract Surgery with a intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Acrysof Toric intraocular lens | Experimental | A One piece, acrylic intraocular lens is implanted in the lens bag. Receives: Procedure: Acrysof Toric one-piece intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralization of Astigmatism
Measured: 3 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925886
- Sponsor's protocol ID
- 07-01
- Status last verified
- May 2024
- First submitted
- 18 Jun 2009
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
PubMed 18721707
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
- ClinicalTrials.gov ID
- NCT00925886
- Acronym / sponsor ID
- 07-01
- Conditions
- Cataract, Astigmatism
- Keywords
- Astigmatism, Cataract
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Jun 2009 (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 evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens.
Detailed description
Patients with Cataract are treated with phacoemulsification of the lens with an implantation of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an implantation of a toric intraocular lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acrysof Toric intraocular lens | Experimental | Procedure: Acrysof Toric one-piece intraocular lensA One piece, acrylic intraocular lens is implanted in the lens bag. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.
Key exclusion criteria (3 listed)
- Irregular astigmatism,
- Keratoconus,
- Previous Refractive Surgery.
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 |
|---|---|---|
| Acrysof Toric one-piece intraocular lensAlso: Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INCCataract Surgery with a intraocular lens implantation | Procedure or surgery | Acrysof Toric intraocular lens |
Primary outcome
Neutralization of Astigmatism
Time frame: 3 months after cataract surgery
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 18721707Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acrysof Toric one-piece intraocular lens in people with Cataract and Astigmatism, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Jun 2024. 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 Mexico. 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 was stopped early (reason given: Poor accrual). Results are not available in the source record.
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?
Neutralization of Astigmatism (time frame: 3 months after cataract surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00925886, which also lists 1 linked publication.
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 3 Jun 2024.