AstigmatismNCT02067429
Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
A study testing Limbal Relaxing Incisions and Toric Intraocular Lens in people with Astigmatism and Cataract, run by Christin Henein at 1 site in United Kingdom.
Trial summary
This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in correcting astigmatism in patient undergoing standard cataract surgery. Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Cataract
- What is being tested?
- Limbal Relaxing Incisions and Toric Intraocular Lens
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic cataract for which the patient desires surgery
- Corneal astigmatism of greater than or equal to 0.75 D and lesser than or equal to 2.5D.
- No significant ophthalmic co-morbidity which would affect the postoperative visual outcomes.
Who cannot join
- <18 years of age
- Significant ophthalmic comorbidity detrimental to final visual outcomes
- Not competent to give consent
- Concurrent use of ocular medications including lubricants
- Unable to attend follow ups at 1, 3, 6 and 12 months.
Trial locations and contacts
1 site in 1 country.
Deborah Horney contact
United Kingdom1 site, 1 recruiting
- Recruiting
Sussex Eye Hospital
Brighton, BN2 5BF
Deborah Horney, Deborah.Horney2@bsuh.nhs.uk
Mayank Nanavaty, DO, MRCSEd, FRCOphth
About this study
Official title: Limbal Relaxing Incisions Versus Toric Intraocular Lens for Keratometric Astigmatism <2.5 Diopters in Patients Undergoing Cataract Surgery and Intraocular Lens Implantation.
This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in correcting astigmatism in patient undergoing standard cataract surgery.
Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical. Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have astigmatism which is likely to have been corrected by spectacles.
Read more
Cataract surgery involves the replacement of the natural opacifying crystalline lens with a clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct the patient's glasses prescription. The most widely used IOLs only correct glasses at one distance i.e. either near or distance. Residual astigmatism after cataract surgery will need glasses for correction which is undesirable for many patients.
Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and have no additional risk of complications.
Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have been available for routine use in the last few years; technology has markedly improved and the lenses have become cheaper.
Studies have suggested toric IOLs provide better vision after cataract surgery than the regular IOLs. Toric IOL are widely used in the private practice and increasingly in the National Health Service (NHS). LRIs are cost effective for treating astigmatism however their predictability is believed to be lower than toric IOLs. As there are no randomised controlled trials comparing the outcomes between LRIs and toric IOLs. This research will address this gap in knowledge and accordingly from this research future practice will be able to provide treatment to patients with information about the best outcomes.
- Conditions
- Astigmatism, Cataract
- Being tested
- Limbal Relaxing Incisions, Toric Intraocular Lens
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limbal Relaxing IncisionsProcedure or surgery
Toric Intraocular LensDevice
| Study group | Role | What they receive |
|---|---|---|
| Toric Intraocular lens | Experimental | Toric intraocular lens implantation during standard cataract surgery Receives: Device: Toric Intraocular Lens |
| Limbal Relaxing Incisions | Experimental | Limbal relaxing incisions during standard cataract surgery Receives: Procedure: Limbal Relaxing Incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaided distance LogMAR visual acuity (UDVA)
Measured: 1 months
Unaided distance LogMAR visual acuity (UDVA)
Measured: 3 months
Unaided distance LogMAR visual acuity (UDVA)
Measured: 6 months
Unaided distance LogMAR visual acuity (UDVA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christin Henein
- Sponsor type
- Other government
- Collaborators
- Rayner Intraocular Lenses Limited
- Responsible party
- Sponsor-investigator, Christin Henein, Sussex Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067429
- Sponsor's protocol ID
- RCT135670
- Status last verified
- Nov 2014
- First submitted
- 17 Feb 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limbal Relaxing Incisions Versus Toric Intraocular Lens for Keratometric Astigmatism <2.5 Diopters in Patients Undergoing Cataract Surgery and Intraocular Lens Implantation.
- ClinicalTrials.gov ID
- NCT02067429
- Acronym / sponsor ID
- RCT135670
- Conditions
- Astigmatism, Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Christin HeneinOther government
- Collaborators
- Rayner Intraocular Lenses Limited
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 20 Feb 2014 (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.
This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in correcting astigmatism in patient undergoing standard cataract surgery.
Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical. Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have astigmatism which is likely to have been corrected by spectacles.
Cataract surgery involves the replacement of the natural opacifying crystalline lens with a clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct the patient's glasses prescription. The most widely used IOLs only correct glasses at one distance i.e. either near or distance. Residual astigmatism after cataract surgery will need glasses for correction which is undesirable for many patients.
Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and have no additional risk of complications.
Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have been available for routine use in the last few years; technology has markedly improved and the lenses have become cheaper.
Studies have suggested toric IOLs provide better vision after cataract surgery than the regular IOLs. Toric IOL are widely used in the private practice and increasingly in the National Health Service (NHS). LRIs are cost effective for treating astigmatism however their predictability is believed to be lower than toric IOLs. As there are no randomised controlled trials comparing the outcomes between LRIs and toric IOLs. This research will address this gap in knowledge and accordingly from this research future practice will be able to provide treatment to patients with information about the best outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric Intraocular lens | Experimental | Device: Toric Intraocular LensToric intraocular lens implantation during standard cataract surgery |
| Limbal Relaxing Incisions | Experimental | Procedure: Limbal Relaxing IncisionsLimbal relaxing incisions during standard cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic cataract for which the patient desires surgery
- Corneal astigmatism of greater than or equal to 0.75 D and lesser than or equal to 2.5D.
- No significant ophthalmic co-morbidity which would affect the postoperative visual outcomes.
Key exclusion criteria (5 listed)
- <18 years of age
- Significant ophthalmic comorbidity detrimental to final visual outcomes
- Not competent to give consent
- Concurrent use of ocular medications including lubricants
- Unable to attend follow ups at 1, 3, 6 and 12 months.
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 |
|---|---|---|
| Limbal Relaxing Incisions | Procedure or surgery | Limbal Relaxing Incisions |
| Toric Intraocular Lens | Device | Toric Intraocular lens |
Primary outcome
Unaided distance LogMAR visual acuity (UDVA)
Time frame: 1 months
Unaided distance LogMAR visual acuity (UDVA)
Time frame: 3 months
Unaided distance LogMAR visual acuity (UDVA)
Time frame: 6 months
Unaided distance LogMAR visual acuity (UDVA)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Deborah Horney contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limbal Relaxing Incisions and Toric Intraocular Lens in people with Astigmatism and Cataract, run by Christin Henein at 1 site in United Kingdom.
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 5 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 2 Dec 2014. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah Horney (Deborah.Horney2@bsuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unaided distance LogMAR visual acuity (UDVA) (time frame: 1 months). The study lists 4 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 2 Dec 2014.