AstigmatismNCT01075542
Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens
A study testing AcrySof Toric intraocular lens, model SN60TT and AcrySof Monofocal IOL, model SN60AT in people with Astigmatism, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- AcrySof Toric intraocular lens, model SN60TT and AcrySof Monofocal IOL, model SN60AT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2010to Nov 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral cataract
- Bilateral corneal astigmatism (at least 1.25D)
- Predicted residual astigmatism less than 0.5D
Who cannot join
- Irregular corneal astigmatism or keratoconus
- Fuchs endothelial dystrophy (stage 2)
- Expected postoperative best-corrected visual acuity worse than logMAR +0.3
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Atrium Medical Center
Heerlen, Brunssum, Kerkrade
Maastricht University Medical Center
Maastricht, 6229 HX
Rotterdam Eye Hospital
Rotterdam
About this study
Official title: Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.
Read the detailed description
A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. Good near vision may subsequently be achieved with low-cost reading glasses. The current practice of non-toric IOL implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision.
Objective: The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness.
Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery.
Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).
- Conditions
- Astigmatism
- Being tested
- AcrySof Toric intraocular lens, model SN60TT, AcrySof Monofocal IOL, model SN60AT
- Keywords
- Corneal astigmatism, Intraocular lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof Toric intraocular lens, model SN60TTDevice
The lens is made of foldable acrylic material and is implanted in the capsular bag
AcrySof Monofocal IOL, model SN60ATDevice
The lens is made of foldable acrylic material and is implanted in the capsular bag
| Study group | Role | What they receive |
|---|---|---|
| Toric intraocular lens | Experimental | Bilateral Toric intraocular lens implantation in cataract surgery Receives: Device: AcrySof Toric intraocular lens, model SN60TT |
| Monofocal intraocular lens | Other | Bilateral Monofocal intraocular lens implantation in cataract surgery Receives: Device: AcrySof Monofocal IOL, model SN60AT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectacle independency
Spectacle independency for distance vision
Measured: preop, 3 months and 6 months postop
Secondary outcomes (6)
Visual acuity
Measured: preop, 1 day, 1 month, 3 months and 6 months postop
Refractive astigmatism
Measured: preop, 3 months and 6 months postop
Higher-order wavefront aberrations
Measured: preop, 3 months and 6 months postop
Contrast sensitivity
Measured: preop, 3 months and 6 months postop
Costs related to intervention
Total cost-analysis, including out-of-hospital costs for patient
Measured: preop, 3 and 6 months postop
Quality of vision
Refractive-error related quality of vision
Measured: preop, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Rudy Nuijts, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075542
- Sponsor's protocol ID
- 082099
- Status last verified
- Jan 2014
- First submitted
- 24 Feb 2010
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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 18721707Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602.
PubMed 25256624
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01075542
- Acronym / sponsor ID
- 082099
- Conditions
- Astigmatism
- Keywords
- Corneal astigmatism, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Feb 2010 (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 determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.
Detailed description
A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. Good near vision may subsequently be achieved with low-cost reading glasses. The current practice of non-toric IOL implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision.
Objective: The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness.
Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery.
Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric intraocular lens | Experimental | Device: AcrySof Toric intraocular lens, model SN60TTBilateral Toric intraocular lens implantation in cataract surgery |
| Monofocal intraocular lens | Other | Device: AcrySof Monofocal IOL, model SN60ATBilateral Monofocal intraocular lens implantation in cataract surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral cataract
- Bilateral corneal astigmatism (at least 1.25D)
- Predicted residual astigmatism less than 0.5D
Key exclusion criteria (3 listed)
- Irregular corneal astigmatism or keratoconus
- Fuchs endothelial dystrophy (stage 2)
- Expected postoperative best-corrected visual acuity worse than logMAR +0.3
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 intraocular lens, model SN60TTThe lens is made of foldable acrylic material and is implanted in the capsular bag | Device | Toric intraocular lens |
| AcrySof Monofocal IOL, model SN60ATThe lens is made of foldable acrylic material and is implanted in the capsular bag | Device | Monofocal intraocular lens |
Primary outcome
Spectacle independency
Time frame: preop, 3 months and 6 months postop
Spectacle independency for distance vision
6 secondary outcomes
Visual acuity
Time frame: preop, 1 day, 1 month, 3 months and 6 months postop
Refractive astigmatism
Time frame: preop, 3 months and 6 months postop
Higher-order wavefront aberrations
Time frame: preop, 3 months and 6 months postop
Contrast sensitivity
Time frame: preop, 3 months and 6 months postop
Costs related to intervention
Time frame: preop, 3 and 6 months postop
Quality of vision
Time frame: preop, 3 months, 6 months
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 14 Jan 2014.
- 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.
- Derived from this study: PubMed 25256624Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602.
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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.
Rudy Nuijts, MD, PhD principal investigator
Maastricht University Medical Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof Toric intraocular lens, model SN60TT and AcrySof Monofocal IOL, model SN60AT in people with Astigmatism, run by Maastricht University Medical Center at 3 sites in Netherlands.
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 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: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Spectacle independency (time frame: preop, 3 months and 6 months postop). 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 NCT01075542, which also lists 2 linked publications.
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 14 Jan 2014.