CataractPhase 4NCT02264457
A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses
A Phase 4 study testing T-flex Aspheric Toric IOL and AT TORBI toric IOL in people with Cataract, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- T-flex Aspheric Toric IOL and AT TORBI toric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jan 2020
- Phase
- Phase 4
- 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
- Age 50-75 years, bilateral significant corneal astigmatism >1.50D.
- Requiring a Toric IOL within the following power range:
- Sphere +6.00D to +30.00D
- Cylinder +1.00D to +6.00D
Who cannot join
- Amblyopia,
- predicted bilateral post-op corneal astigmatism of <1.50D,
- irregular astigmatism,
- dilated pupil size smaller than 5mm,
- macular pathology,
- glaucoma,
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- retinal disease,
- corneal disease,
- abnormal iris,
- pupil deformation and
- any previous corneal or intraocular surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
BMI Southend Private Hospital
Westcliff-on-Sea, Essex, SS09AG
Maralyn Cole, 01702 608908, Maralyn.Cole@bmihealthcare.co.uk
Elizabeth Law, BSc(hons), elizabeth.law@plymouth.ac.uk
About this study
Official title: A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism
During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.
- Conditions
- Cataract
- Being tested
- T-flex Aspheric Toric IOL, AT TORBI toric IOL
- Keywords
- Lenses, Intraocular
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-flex Aspheric Toric IOLDevice
AT TORBI toric IOLDevice
| Study group | Role | What they receive |
|---|---|---|
| First eye closed loop haptic | Other | subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery Receives: Device: T-flex Aspheric Toric IOL; Device: AT TORBI toric IOL |
| First eye plate haptic | Other | subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery Receives: Device: T-flex Aspheric Toric IOL; Device: AT TORBI toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Measured: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months
Secondary outcomes (4)
Manifest refraction
Measured: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
Rotational stability
Measured: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
IOL centration
Measured: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
Prevalence of posterior capsular Opacification
Measured: visit 4 (3-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJun 2015
- Primary completion1 Dec 2019 (estimated)
- Study completionJan 2020 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- BMI Southend Hospital
- Responsible party
- Principal investigator, Dr Phillip J Buckhurst, University of Plymouth
- Investigators
- Phillip J Buckhurst, PhD, Principal investigator, Plymouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264457
- Sponsor's protocol ID
- IISR-2014-003
- Status last verified
- Jan 2019
- First submitted
- 8 Oct 2014
- Last updated
- 23 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism
- ClinicalTrials.gov ID
- NCT02264457
- Acronym / sponsor ID
- IISR-2014-003
- Conditions
- Cataract
- Keywords
- Lenses, Intraocular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- BMI Southend Hospital
- Study start
- Jun 2015
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 15 Oct 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.
During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First eye closed loop haptic | Other | Device: T-flex Aspheric Toric IOL, Device: AT TORBI toric IOLsubjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery |
| First eye plate haptic | Other | Device: T-flex Aspheric Toric IOL, Device: AT TORBI toric IOLsubjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50-75 years, bilateral significant corneal astigmatism >1.50D.
- Requiring a Toric IOL within the following power range:
- Sphere +6.00D to +30.00D
- Cylinder +1.00D to +6.00D
Key exclusion criteria (11 listed)
- Amblyopia,
- predicted bilateral post-op corneal astigmatism of <1.50D,
- irregular astigmatism,
- dilated pupil size smaller than 5mm,
- macular pathology,
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 |
|---|---|---|
| T-flex Aspheric Toric IOL | Device | First eye closed loop haptic, First eye plate haptic |
| AT TORBI toric IOL | Device | First eye closed loop haptic, First eye plate haptic |
Primary outcome
Best-corrected visual acuity
Time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months
4 secondary outcomes
Manifest refraction
Time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
Rotational stability
Time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
IOL centration
Time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
Prevalence of posterior capsular Opacification
Time frame: visit 4 (3-4 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
Phillip J Buckhurst, PhD principal investigator
Plymouth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing T-flex Aspheric Toric IOL and AT TORBI toric IOL in people with Cataract, run by University of Plymouth 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 4 inclusion and 11 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 Jan 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Phillip J Buckhurst, PhD (+44 (0) 1752 588884, phillip.buckhurst@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months). 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 Jan 2019.