Clinical trial NCT04175951: Tecnis Eyhance Versus Rayner RayOne Study
Official title: Visual and Optical Outcomes After Bilateral Implantation of Tecnis Eyhance Versus Rayner RayOne Aspheric in Patients Undergoing Routine Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract Senile
Pseudophakia
Keywords: cataract
intraocular lens
intermediate vision
Lead sponsor: Brighton and Sussex University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Unaided distance visual acuity (UCDVA) (Uniocular and binocular)
timeFrame: 3 months postoperatively
measure: Unaided intermediate visual acuity (UIVA) (uniocular and binocular)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Best corrected distance LogMAR visual acuity (CDVA) (uniocular and binocular)
timeFrame: 1 and 3 months postoperatively
measure: Manifest refraction (Diopters)
timeFrame: 1 and 3 months postoperatively
measure: Defocus Curves (Diopters)
timeFrame: 1 and 3 months postoperatively
measure: Distance correct intermediate LogMAR visual acuity (DCIVA) at 60 cm
timeFrame: 1 and 3 months postoperatively
measure: Wavefront aberrometry using iTrace Tracey aberrometer (Internal and total higher order and lower order aberrations)(microns)
timeFrame: 1 and 3 months postoperatively
measure: Quality of life outcomes assessment by the Catquest 9SF questionnaire
timeFrame: 1 and 3 months postoperatively
measure: Glare and halos questionnaire on 1-4 Likert scale
timeFrame: 1 and 3 months postoperatively
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University Hospitals NHS Trust
state: Sussex
Study officials:
affiliation: Brighton and Sussex University Hospitals NHS Trust
name: Mayank Nanavaty, FRCOphth,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.