CataractNCT01712503
A Trial of Toric Versus Non-toric Intraocular Lenses in Phacoemulsification Cataract Surgery
A study testing Phacoemulsfication cataract surgery and intra-ocular lens implant in people with Cataract and Astigmatism, run by Western Sussex Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is a randomised controlled trial that formally compares intra-ocular lenses, which can be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is the newer toric lens which can correct astgimatism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Phacoemulsfication cataract surgery and intra-ocular lens implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jan 2014
- 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
- Healthy volunteers accepted
- 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 2 dioptres
- No significant ophthalmic comorbidity
Who cannot join
- <18 years of age
- Significant ophthalmic co-morbidity
- Pregnant
- Medically unfit for cataract surgery
- Not competent to give consent
Trial locations and contacts
1 site in 1 country.
Masoud Teimory contact
Saul Rajak contact
United Kingdom1 site
Western Sussex Hospital Trust
Worthing and Chichester, West Sussex
Masoud Teimory, masoud.teimory@wsht.nhs.uk
Saul Rajak, saul.rajak@lshtm.ac.uk
About this study
This is a randomised controlled trial that formally compares intra-ocular lenses, which can be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is the newer toric lens which can correct astgimatism.
The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract surgery. The alternative hypothesis is that the toric lens, provides a better unaided (without glasses) vision, by correcting the participant's astigmatism.
Read more
It has been decided to conduct a randomised controlled trial of the two lenses, as although the toric lenses are endorsed by many case series (which show a reduction in astigmatism), they have not been formally compared to the standard lens. An RCT will enable the formal comparison.
It is expected that this trial will take approximately a year to conduct: six months of recruitment and six months of follow-up. A further six months will be required to analyse the data and prepare a manuscript for publication.
The investigators do not plan to conduct an interim analysis or report as this is a short-trial (six months follow-up) using two alternative lens that are CE marked and already widely used.
Participants who have both cataract and astigmatism will be identified from the GP/optometrist referral letter. They will be seen in specially designated clinics for this research study, which will run alongside the routine cataract 'one' stop clinics at St Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be part of the study to have all the necessary examination done in one visit and for those who decline participation to be seen in the regular cataract clinic. Potential participants will be sent the research trial information (appendix A) with their appointment letter.
After introducing himself the researcher (who is also a senior cataract surgeon at Western Sussex Hospital Trust), will check if potential participants have had the opportunity to read the trial information that they were sent, or give participants a further copy as required. The key points of the trial will be re-iterated by the researcher and they will be invited to ask any questions about the trialThe researcher will check that the potential participant has read and understood the participant information leaflet. They will answer any questions that the potential participant has and will then take signed consent from those willing to participate.
Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the participant prefers, after consultation with the researcher or surgeon, to have operated first. The participant will be allocated a unique study reference number.
Patients who decline to take part in the trial will be offered cataract surgery as per usual WSHT/NHS procedure.
- Conditions
- Cataract, Astigmatism
- Being tested
- Phacoemulsfication cataract surgery and intra-ocular lens implant
- Keywords
- Cataract, Astigmatism, Toric, Phacoemulsification, Intraocular lens
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsfication cataract surgery and intra-ocular lens implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Toric intraocular lens | Experimental | TFlex Lens (623T) Receives: Device: Phacoemulsfication cataract surgery and intra-ocular lens implant |
| Monofocal intraocular lens | Placebo comparator | Superflex Aspheric Lens (920H)/Cflex Aspheric Lens (970C) Receives: Device: Phacoemulsfication cataract surgery and intra-ocular lens implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaided LogMAR visual acuity at 2 months post-operatively
Secondary outcomes (4)
Unaided LogMAR visual acuity at 2 weeks and 6 months post-operatively
Corrected visual acuity at 2 months and 6 months post-operatively
Residual spherical and cylindrical prescriptions at 2 weeks, 2 months and 6 months post-operatively
Patients quality of life questionnaire to assess subjective vision, glare at day/night, subjective colour perception, other symptoms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sussex Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Rayner Intraocular Lenses Ltd
- Responsible party
- Principal investigator, Mr Masoud Teimory, Western Sussex Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712503
- Sponsor's protocol ID
- 1518/WSHT/2012
- Status last verified
- Oct 2012
- First submitted
- 19 Oct 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Toric Versus Non-toric Intraocular Lenses in Phacoemulsification Cataract Surgery
- ClinicalTrials.gov ID
- NCT01712503
- Acronym / sponsor ID
- 1518/WSHT/2012
- Conditions
- Cataract, Astigmatism
- Keywords
- Cataract, Astigmatism, Toric, Phacoemulsification, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Western Sussex Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Rayner Intraocular Lenses Ltd
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 23 Oct 2012 (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 is a randomised controlled trial that formally compares intra-ocular lenses, which can be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is the newer toric lens which can correct astgimatism.
The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract surgery. The alternative hypothesis is that the toric lens, provides a better unaided (without glasses) vision, by correcting the participant's astigmatism.
It has been decided to conduct a randomised controlled trial of the two lenses, as although the toric lenses are endorsed by many case series (which show a reduction in astigmatism), they have not been formally compared to the standard lens. An RCT will enable the formal comparison.
It is expected that this trial will take approximately a year to conduct: six months of recruitment and six months of follow-up. A further six months will be required to analyse the data and prepare a manuscript for publication.
The investigators do not plan to conduct an interim analysis or report as this is a short-trial (six months follow-up) using two alternative lens that are CE marked and already widely used.
Participants who have both cataract and astigmatism will be identified from the GP/optometrist referral letter. They will be seen in specially designated clinics for this research study, which will run alongside the routine cataract 'one' stop clinics at St Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be part of the study to have all the necessary examination done in one visit and for those who decline participation to be seen in the regular cataract clinic. Potential participants will be sent the research trial information (appendix A) with their appointment letter.
After introducing himself the researcher (who is also a senior cataract surgeon at Western Sussex Hospital Trust), will check if potential participants have had the opportunity to read the trial information that they were sent, or give participants a further copy as required. The key points of the trial will be re-iterated by the researcher and they will be invited to ask any questions about the trialThe researcher will check that the potential participant has read and understood the participant information leaflet. They will answer any questions that the potential participant has and will then take signed consent from those willing to participate.
Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the participant prefers, after consultation with the researcher or surgeon, to have operated first. The participant will be allocated a unique study reference number.
Patients who decline to take part in the trial will be offered cataract surgery as per usual WSHT/NHS procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric intraocular lens | Experimental | Device: Phacoemulsfication cataract surgery and intra-ocular lens implantTFlex Lens (623T) |
| Monofocal intraocular lens | Placebo comparator | Device: Phacoemulsfication cataract surgery and intra-ocular lens implantSuperflex Aspheric Lens (920H)/Cflex Aspheric Lens (970C) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 2 dioptres
- No significant ophthalmic comorbidity
Key exclusion criteria (5 listed)
- <18 years of age
- Significant ophthalmic co-morbidity
- Pregnant
- Medically unfit for cataract surgery
- Not competent to give consent
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 |
|---|---|---|
| Phacoemulsfication cataract surgery and intra-ocular lens implant | Device | Monofocal intraocular lens, Toric intraocular lens |
Primary outcome
Unaided LogMAR visual acuity at 2 months post-operatively
4 secondary outcomes
Unaided LogMAR visual acuity at 2 weeks and 6 months post-operatively
Corrected visual acuity at 2 months and 6 months post-operatively
Residual spherical and cylindrical prescriptions at 2 weeks, 2 months and 6 months post-operatively
Patients quality of life questionnaire to assess subjective vision, glare at day/night, subjective colour perception, other symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Masoud Teimory contact
Saul Rajak 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 Phacoemulsfication cataract surgery and intra-ocular lens implant in people with Cataract and Astigmatism, run by Western Sussex Hospitals NHS Trust 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 23 Oct 2012. 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. Some participants in this study may receive a placebo. 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 Masoud Teimory (masoud.teimory@wsht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unaided LogMAR visual acuity at 2 months post-operatively. 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 23 Oct 2012.