- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175951
Tecnis Eyhance Versus Rayner RayOne Study
Visual and Optical Outcomes After Bilateral Implantation of Tecnis Eyhance Versus Rayner RayOne Aspheric in Patients Undergoing Routine Cataract Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Wendam, RSN
- Phone Number: 3115 01273696955
- Email: maria.wendam@nhs.net
Study Contact Backup
- Name: Sean Gallagher, BMedSci
- Phone Number: 3115 01273696955
- Email: sean.gallagher5@nhs.net
Study Locations
-
-
Sussex
-
Brighton, Sussex, United Kingdom, BN2 5BF
- Recruiting
- Brighton & Sussex University Hospitals NHS Trust
-
Contact:
- Mayank Nanavaty
- Phone Number: 07947166134
- Email: mayank.nanavaty@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tecnis Eyhance
Tecnis Eyhance hydrophobic IOL is a monofocal IOL with added advantage of slightly better unaided intermediate vision at 60 cms.
|
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.
|
Active Comparator: Rayner RayOne
Rayner Rayone is a monofocal hydrophilic IOL which is not intended to give better unaided or near vision.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months postoperatively
|
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
|
3 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected distance LogMAR visual acuity (CDVA) (uniocular and binocular)
Time Frame: 1 and 3 months postoperatively
|
Uniocular and binocular best spectacle corrected distance vision will be measured at the follow ups
|
1 and 3 months postoperatively
|
Manifest refraction (Diopters)
Time Frame: 1 and 3 months postoperatively
|
Sphere, cylinder and axis of the manifest refraction will be recorded at follow ups
|
1 and 3 months postoperatively
|
Defocus Curves (Diopters)
Time Frame: 1 and 3 months postoperatively
|
Defocus curves will be plotted by adding + and - lenses to the manifest refraction
|
1 and 3 months postoperatively
|
Distance correct intermediate LogMAR visual acuity (DCIVA) at 60 cm
Time Frame: 1 and 3 months postoperatively
|
Uniocular and binocular best spectacle corrected intermediate vision will be recorded at follow ups
|
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
|
Aberrometry will be performed using iTrace machine (Tracy Technologies, USA) at all follow up visits
|
1 and 3 months postoperatively
|
Quality of life outcomes assessment by the Catquest 9SF questionnaire
Time Frame: 1 and 3 months postoperatively
|
Patients will be requested to fill a questionnaire at all follow up visits
|
1 and 3 months postoperatively
|
Glare and halos questionnaire on 1-4 Likert scale
Time Frame: 1 and 3 months postoperatively
|
(1= no glare and halos, 2= infrequent; 3 = frequent and 4 = continuous)
|
1 and 3 months postoperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mayank Nanavaty, FRCOphth,PhD, Brighton and Sussex University Hospitals NHS Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 265849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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