CorneaNCT06277349
Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery
A study testing Toric multifocal IOL and Non-toric multifocal IOL in people with Cornea and Astigmatism, run by Moorfields Eye Hospital NHS Foundation Trust.
Trial summary
The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cornea, Astigmatism, Cataract
- What is being tested?
- Toric multifocal IOL and Non-toric multifocal IOL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2009to 4 Jan 2011
- 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 and be planning to have both eyes operated on.
- Age 21 and older
- Have cataracts that allow IOL master biometry
- Regular corneal astigmatism 1.00 up to 2.50 D
- Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D
- written informed consent to surgery and participation in the study
- Speak English
Who cannot join
- Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- Irregular corneal astigmatism on Pentacam topography
About this study
Official title: Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery: A Randomised Trial
The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.
Read the detailed description
This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.
- Conditions
- Cornea, Astigmatism, Cataract
- Being tested
- Toric multifocal IOL, Non-toric multifocal IOL
- Keywords
- multifocal, IOL, astigmatism, incision, cataract surgery, implant
- Medical subject headings
- Corneal Diseases, Astigmatism, Cataract, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toric multifocal IOLDevice
Also called Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007
Implant of Multifocal toric intraocular lens only
Non-toric multifocal IOLDevice
Also called Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use)
Implant of non-toric multifocal lens plus incisional surgery
| Study group | Role | What they receive |
|---|---|---|
| Non toric multifocal IOL combined with corneal incisional surgery | Other | Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use). Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. Corneal limbal relaxing incisions (LRI) according to the Donnenefeld nomogram will be performed combined with standard non-toric multifocal IOL. Receives: Device: Non-toric multifocal IOL |
| Toric multifocal IOL alone | Other | Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007. Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. The multifocal toric IOL will be implanted. Receives: Device: Toric multifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite scoring of unaided distance and near vision (monocularly)
Measurement of uncorrected and best corrected visual acuity will be done using a back-lit EDTRS chart placed at 4m.
Near and distance unaided and corrected visual acuity will be measured, measuring reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk) and contrast vision under photopic and mesopic conditions (Pelli-Robson Chart).
Reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk). The Salzburg Reading Desk (SRD) is the prototype of a reading chart that measures reading speed and reading distance. Contrast and light conditions are preset and reading distance (+/- 0.2 cm), reading speed and their changes during the examination are measured. This ensures an objective evaluation of measurements under the same conditions at every follow-up.
Measured: 3 months
Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon)
Measurement of residual astigmatism will be derived from autorefraction with an autorefractor (Topcon) with mean reading of 5 consecutive measurements in IOL mode, a subjective refraction by an optometrist using trial lenses and the cross cylinder method. All these measurements are non-invasive, non-contact and readily used in daily clinical practice.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start4 Mar 2009
- Primary completion4 Jan 2011
- Study completion4 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277349
- Sponsor's protocol ID
- MAUV1005
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery: A Randomised Trial
- ClinicalTrials.gov ID
- NCT06277349
- Acronym / sponsor ID
- MAUV1005
- Conditions
- Cornea, Astigmatism, Cataract
- Keywords
- multifocal, IOL, astigmatism, incision, cataract surgery, implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Mar 2009 (actual)
- Primary completion
- 4 Jan 2011 (actual)
- Study completion
- 4 Jan 2011 (actual)
- First posted
- 26 Feb 2024 (actual)
- 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 the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.
Detailed description
This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions.
| Arm | Type | Receives |
|---|---|---|
| Non toric multifocal IOL combined with corneal incisional surgery | Other | Device: Non-toric multifocal IOLNon-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use). Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. Corneal limbal relaxing incisions (LRI) according to the Donnenefeld nomogram will be performed combined with standard non-toric multifocal IOL. |
| Toric multifocal IOL alone | Other | Device: Toric multifocal IOLToric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007. Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. The multifocal toric IOL will be implanted. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Bilateral cataract and be planning to have both eyes operated on.
- Age 21 and older
- Have cataracts that allow IOL master biometry
- Regular corneal astigmatism 1.00 up to 2.50 D
- Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D
Key exclusion criteria (2 listed)
- Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- Irregular corneal astigmatism on Pentacam topography
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 |
|---|---|---|
| Toric multifocal IOLAlso: Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007Implant of Multifocal toric intraocular lens only | Device | Toric multifocal IOL alone |
| Non-toric multifocal IOLAlso: Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use)Implant of non-toric multifocal lens plus incisional surgery | Device | Non toric multifocal IOL combined with corneal incisional surgery |
Primary outcome
Composite scoring of unaided distance and near vision (monocularly)
Time frame: 3 months
Measurement of uncorrected and best corrected visual acuity will be done using a back-lit EDTRS chart placed at 4m. Near and distance unaided and corrected visual acuity will be measured, measuring reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk) and contrast vision under photopic and mesopic conditions (Pelli-Robson Chart). Reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk). The Salzburg Reading Desk (SRD) is the prototype of a reading chart that measures reading speed and reading distance. Contrast and light conditions are preset and reading distance (+/- 0.2 cm), reading speed and their changes during the examination are measured. This ensures an objective evaluation of measurements under the same conditions at every follow-up.
Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon)
Time frame: 3 months
Measurement of residual astigmatism will be derived from autorefraction with an autorefractor (Topcon) with mean reading of 5 consecutive measurements in IOL mode, a subjective refraction by an optometrist using trial lenses and the cross cylinder method. All these measurements are non-invasive, non-contact and readily used in daily clinical practice.
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 13 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Toric multifocal IOL and Non-toric multifocal IOL in people with Cornea and Astigmatism, run by Moorfields Eye Hospital NHS Foundation Trust.
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 7 inclusion and 2 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite scoring of unaided distance and near vision (monocularly) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 13 Mar 2024.