Tecnis Eyhance Versus Rayner RayOne Study

NCT04175951 | Unknown

• 1 other identifier: 265849
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile; Pseudophakia

Keywords

cataract; intraocular lens; intermediate vision

Outcome Measures

Primary Outcomes (2)

• Unaided distance visual acuity (UCDVA) (Uniocular and binocular)

  Uniocular and binocular uncorrected distance vision will be measured at the follow ups.

  3 months postoperatively

• Unaided intermediate visual acuity (UIVA) (uniocular and binocular)

  Uniocular and binocular unaided intermediate vision will be measured at the follow ups

  3 months postoperatively

Secondary Outcomes (7)

• Best corrected distance LogMAR visual acuity (CDVA) (uniocular and binocular)

  1 and 3 months postoperatively

• Manifest refraction (Diopters)

  1 and 3 months postoperatively

• Defocus Curves (Diopters)

  1 and 3 months postoperatively

• Distance correct intermediate LogMAR visual acuity (DCIVA) at 60 cm

  1 and 3 months postoperatively

• Wavefront aberrometry using iTrace Tracey aberrometer (Internal and total higher order and lower order aberrations)(microns)

  1 and 3 months postoperatively

Study Arms (2)

Tecnis Eyhance

ACTIVE COMPARATOR

Tecnis Eyhance hydrophobic IOL is a monofocal IOL with added advantage of slightly better unaided intermediate vision at 60 cms.

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.

Device: Intraocular lens

Interventions

Intraocular lens DEVICE

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.

Rayner RayOne; Tecnis Eyhance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (1)

Brighton & Sussex University Hospitals NHS Trust

Brighton, Sussex, BN2 5BF, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 35020542 DERIVED

MeSH Terms

Conditions

Pseudophakia; Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Officials

• Mayank Nanavaty, FRCOphth,PhD

  Brighton and Sussex University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Wendam, RSN

CONTACT

01273696955; maria.wendam@nhs.net

Sean Gallagher, BMedSci

CONTACT

01273696955; sean.gallagher5@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 25, 2019
• Study Start: October 24, 2019
• Primary Completion: May 24, 2020
• Study Completion: October 24, 2020
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)