Cataract SenileNCT04175951
Tecnis Eyhance Versus Rayner RayOne Study
A study testing Intraocular lens in people with Cataract Senile and Pseudophakia, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Cataract surgery involves replacing milky lens with a plastic intraocular lens. This plastic lens can be either monofocal (fixates for distance or near without glasses), extended depth of focus (EDOF)(fixates for intermediate and distance vision only without glasses) or multifocal lenses (fixates for distance… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Senile, Pseudophakia
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2019to 24 Oct 2020
- 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
- Patients undergoing routine cataract surgery with:
- Patients with a symptomatic cataract,
- Postoperative visual potential of 0.2 LogMAR or better
- Corneal astigmatism ≤1.5D
- Patients who are willing to participate in this study.
Who cannot join
- Patients under the age of 18 years,
- Eyes with any ocular comorbidity with cornea, uvea, retina or optic nerve, which may be detrimental to visual outcomes.
- Abnormal corneal topography or any other co-existing retinal or cornea conditions, astigmatism outside the study range,
- Unable to consent and unable to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Brighton & Sussex University Hospitals NHS Trust
Brighton, Sussex, BN2 5BF
Mayank Nanavaty, 07947166134, mayank.nanavaty@nhs.net
About this study
Official title: Visual and Optical Outcomes After Bilateral Implantation of Tecnis Eyhance Versus Rayner RayOne Aspheric in Patients Undergoing Routine Cataract Surgery
Cataract surgery involves replacing milky lens with a plastic intraocular lens. This plastic lens can be either monofocal (fixates for distance or near without glasses), extended depth of focus (EDOF)(fixates for intermediate and distance vision only without glasses) or multifocal lenses (fixates for distance, intermediate and near vision without glasses). However, EDOF and multifocal lenses are known to produce glare and halos. Tecnis Eyhance (Johnson \& Johnson, USA) is a monofocal IOL which give added intermediate vision without employing EDOF or multifocal technology and hence induces no glare and halos. Whereas monofocal IOLs such as RayOne do not give intermediate vision. The objective is to assess visual and optical performance of Tecnis Eyhance versus Rayner RayOne in a prospective, randomized, comparative bilateral study. The proposed study will be the first study comparing the new technology monofocal Eyhance with conventional RayOne Rayner lens to assess the added benefits of Eyhance technology at multiple visits until 3 months after the surgery. Patients attending the clinics with cataracts will be invited to participate in this randomised study. They will be randomised to receive either Eyhance or RayOne in both eyes through surgeries performed not more than 2 weeks apart. The patients will be followed up at 1 and 3 months in the research clinic to assess the uniocular and binocular vision, spectacle prescription, a simple non-invasive scan to look at any distortions in the optics of the eye (wavefront aberrometry) and questionnaire for assessing subjective outcomes, glare and halos.
Read the detailed description
Study design:
Prospective, randomised, comparative study assessing visual and optical outcomes after bilateral implantation of the new Johnson \& Johnson Tecnis Eyhance versus monofocal Rayner RayOne in patients undergoing routine cataract surgery.
Methodology:
Suitable patients with cataracts in both eyes will be identified from cataract assessment clinics. They will be invited to participate in the study by the research nurse and handed over the patient information sheet and a consent form. The PI will consent the patient for the participation. If they agree to participate, they will be give the dates for their surgeries on the same day. The patients can choose to have both eyes done on the same day or two eyes within 2 weeks based on the patients convenience. If they chose to participate in the study, then the patient will have additional tests performed on the day of their cataract assessment clinic. This will take an additional 40 minutes.
On the day of the surgery, the patients will be randomised using a computer generated randomisation to receive either Tecnis Eyhance or the Rayner RayOne lens. They will have the same lens in both eyes. The patients will be invited for a research follow up visit at 1 (between 30-37 days after 2nd eye surgery) and 3 months (90-100 days after 2nd eye surgery) were simple research tests will performed including vision assessment and a scan.
At preoperative visit and 3 months the patients will be asked to fill in a questionnaire.
- Conditions
- Cataract Senile, Pseudophakia
- Being tested
- Intraocular lens
- Keywords
- cataract, intraocular lens, intermediate vision
- Medical subject headings
- Pseudophakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Tecnis Eyhance is a monofocal IOL which give added intermediate vision without employing EDOF or multifocal technology and hence induces no glare and halos. Whereas monofocal IOLs such as RayOne do not give intermediate vision.
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Eyhance | Active comparator | Tecnis Eyhance hydrophobic IOL is a monofocal IOL with added advantage of slightly better unaided intermediate vision at 60 cms. Receives: Device: Intraocular lens |
| Rayner RayOne | Active comparator | Rayner Rayone is a monofocal hydrophilic IOL which is not intended to give better unaided or near vision. Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaided distance visual acuity (UCDVA) (Uniocular and binocular)
Uniocular and binocular uncorrected distance vision will be measured at the follow ups.
Measured: 3 months postoperatively
Unaided intermediate visual acuity (UIVA) (uniocular and binocular)
Uniocular and binocular unaided intermediate vision will be measured at the follow ups
Measured: 3 months postoperatively
Secondary outcomes (7)
Best corrected distance LogMAR visual acuity (CDVA) (uniocular and binocular)
Uniocular and binocular best spectacle corrected distance vision will be measured at the follow ups
Measured: 1 and 3 months postoperatively
Manifest refraction (Diopters)
Sphere, cylinder and axis of the manifest refraction will be recorded at follow ups
Measured: 1 and 3 months postoperatively
Defocus Curves (Diopters)
Defocus curves will be plotted by adding + and - lenses to the manifest refraction
Measured: 1 and 3 months postoperatively
Distance correct intermediate LogMAR visual acuity (DCIVA) at 60 cm
Uniocular and binocular best spectacle corrected intermediate vision will be recorded at follow ups
Measured: 1 and 3 months postoperatively
Wavefront aberrometry using iTrace Tracey aberrometer (Internal and total higher order and lower order aberrations)(microns)
Aberrometry will be performed using iTrace machine (Tracy Technologies, USA) at all follow up visits
Measured: 1 and 3 months postoperatively
Quality of life outcomes assessment by the Catquest 9SF questionnaire
Patients will be requested to fill a questionnaire at all follow up visits
Measured: 1 and 3 months postoperatively
Glare and halos questionnaire on 1-4 Likert scale
(1= no glare and halos, 2= infrequent; 3 = frequent and 4 = continuous)
Measured: 1 and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start24 Oct 2019
- Primary completion24 May 2020 (estimated)
- Study completion24 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mayank Nanavaty, FRCOphth,PhD, Principal investigator, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175951
- Sponsor's protocol ID
- 265849
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nanavaty MA, Ashena Z, Gallagher S, Borkum S, Frattaroli P, Barbon E. Visual Acuity, Wavefront Aberrations, and Defocus Curves With an Enhanced Monofocal and a Monofocal Intraocular Lens: A Prospective, Randomized Study. J Refract Surg. 2022 Jan;38(1):10-20. doi: 10.3928/1081597X-20211109-02. Epub 2022 Jan 1.
PubMed 35020542
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Optical Outcomes After Bilateral Implantation of Tecnis Eyhance Versus Rayner RayOne Aspheric in Patients Undergoing Routine Cataract Surgery
- ClinicalTrials.gov ID
- NCT04175951
- Acronym / sponsor ID
- 265849
- Conditions
- Cataract Senile, Pseudophakia
- Keywords
- cataract, intraocular lens, intermediate vision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 24 May 2020 (estimated)
- Study completion
- 24 Oct 2020 (estimated)
- First posted
- 25 Nov 2019 (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.
Cataract surgery involves replacing milky lens with a plastic intraocular lens. This plastic lens can be either monofocal (fixates for distance or near without glasses), extended depth of focus (EDOF)(fixates for intermediate and distance vision only without glasses) or multifocal lenses (fixates for distance, intermediate and near vision without glasses). However, EDOF and multifocal lenses are known to produce glare and halos. Tecnis Eyhance (Johnson \& Johnson, USA) is a monofocal IOL which give added intermediate vision without employing EDOF or multifocal technology and hence induces no glare and halos. Whereas monofocal IOLs such as RayOne do not give intermediate vision. The objective is to assess visual and optical performance of Tecnis Eyhance versus Rayner RayOne in a prospective, randomized, comparative bilateral study. The proposed study will be the first study comparing the new technology monofocal Eyhance with conventional RayOne Rayner lens to assess the added benefits of Eyhance technology at multiple visits until 3 months after the surgery. Patients attending the clinics with cataracts will be invited to participate in this randomised study. They will be randomised to receive either Eyhance or RayOne in both eyes through surgeries performed not more than 2 weeks apart. The patients will be followed up at 1 and 3 months in the research clinic to assess the uniocular and binocular vision, spectacle prescription, a simple non-invasive scan to look at any distortions in the optics of the eye (wavefront aberrometry) and questionnaire for assessing subjective outcomes, glare and halos.
Detailed description
Study design:
Prospective, randomised, comparative study assessing visual and optical outcomes after bilateral implantation of the new Johnson \& Johnson Tecnis Eyhance versus monofocal Rayner RayOne in patients undergoing routine cataract surgery.
Methodology:
Suitable patients with cataracts in both eyes will be identified from cataract assessment clinics. They will be invited to participate in the study by the research nurse and handed over the patient information sheet and a consent form. The PI will consent the patient for the participation. If they agree to participate, they will be give the dates for their surgeries on the same day. The patients can choose to have both eyes done on the same day or two eyes within 2 weeks based on the patients convenience. If they chose to participate in the study, then the patient will have additional tests performed on the day of their cataract assessment clinic. This will take an additional 40 minutes.
On the day of the surgery, the patients will be randomised using a computer generated randomisation to receive either Tecnis Eyhance or the Rayner RayOne lens. They will have the same lens in both eyes. The patients will be invited for a research follow up visit at 1 (between 30-37 days after 2nd eye surgery) and 3 months (90-100 days after 2nd eye surgery) were simple research tests will performed including vision assessment and a scan.
At preoperative visit and 3 months the patients will be asked to fill in a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis Eyhance | Active comparator | Device: Intraocular lensTecnis Eyhance hydrophobic IOL is a monofocal IOL with added advantage of slightly better unaided intermediate vision at 60 cms. |
| Rayner RayOne | Active comparator | Device: Intraocular lensRayner Rayone is a monofocal hydrophilic IOL which is not intended to give better unaided or near vision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing routine cataract surgery with:
Key exclusion criteria (4 listed)
- Patients under the age of 18 years,
- Eyes with any ocular comorbidity with cornea, uvea, retina or optic nerve, which may be detrimental to visual outcomes.
- Abnormal corneal topography or any other co-existing retinal or cornea conditions, astigmatism outside the study range,
- Unable to consent and unable to attend follow-up visits
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 |
|---|---|---|
| Intraocular lensTecnis Eyhance is a monofocal IOL which give added intermediate vision without employing EDOF or multifocal technology and hence induces no glare and halos. Whereas monofocal IOLs such as RayOne do not give intermediate vision. | Device | Rayner RayOne, Tecnis Eyhance |
Primary outcome
Unaided distance visual acuity (UCDVA) (Uniocular and binocular)
Time frame: 3 months postoperatively
Uniocular and binocular uncorrected distance vision will be measured at the follow ups.
Unaided intermediate visual acuity (UIVA) (uniocular and binocular)
Time frame: 3 months postoperatively
Uniocular and binocular unaided intermediate vision will be measured at the follow ups
7 secondary outcomes
Best corrected distance LogMAR visual acuity (CDVA) (uniocular and binocular)
Time frame: 1 and 3 months postoperatively
Manifest refraction (Diopters)
Time frame: 1 and 3 months postoperatively
Defocus Curves (Diopters)
Time frame: 1 and 3 months postoperatively
Distance correct intermediate LogMAR visual acuity (DCIVA) at 60 cm
Time frame: 1 and 3 months postoperatively
Wavefront aberrometry using iTrace Tracey aberrometer (Internal and total higher order and lower order aberrations)(microns)
Time frame: 1 and 3 months postoperatively
Quality of life outcomes assessment by the Catquest 9SF questionnaire
Time frame: 1 and 3 months postoperatively
Glare and halos questionnaire on 1-4 Likert scale
Time frame: 1 and 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 35020542Nanavaty MA, Ashena Z, Gallagher S, Borkum S, Frattaroli P, Barbon E. Visual Acuity, Wavefront Aberrations, and Defocus Curves With an Enhanced Monofocal and a Monofocal Intraocular Lens: A Prospective, Randomized Study. J Refract Surg. 2022 Jan;38(1):10-20. doi: 10.3928/1081597X-20211109-02. Epub 2022 Jan 1.
- Individual participant dataSharing planned: No
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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.
Mayank Nanavaty, FRCOphth,PhD principal investigator
Brighton and Sussex University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens in people with Cataract Senile and Pseudophakia, run by Brighton and Sussex University 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 5 inclusion and 4 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 25 Nov 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.
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 Maria Wendam, RSN (01273696955 ext. 3115, maria.wendam@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unaided distance visual acuity (UCDVA) (Uniocular and binocular) (time frame: 3 months postoperatively). 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?
On the ClinicalTrials.gov record for NCT04175951, which also lists 1 linked publication.
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 25 Nov 2019.