Tecnis Eyhance Versus Rayner RayOne Study

Cataract Senile Clinical Trial

Official title:

Visual and Optical Outcomes After Bilateral Implantation of Tecnis Eyhance Versus Rayner RayOne Aspheric in Patients Undergoing Routine Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04175951
• Other study ID #: 265849
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: October 24, 2020

Study information

• Verified date: November 2019
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: Maria Wendam, RSN
• Phone: 01273696955
• Email: maria.wendam[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 24, 2020
• Est. primary completion date: May 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Pseudophakia

Intervention

Device:
• Intraocular lens
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.

Locations

Country	Name	City	State
United Kingdom	Brighton & Sussex University Hospitals NHS Trust	Brighton	Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unaided distance visual acuity (UCDVA) (Uniocular and binocular)	Uniocular and binocular uncorrected distance vision will be measured at the follow ups.	3 months postoperatively
Primary	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	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	1 and 3 months postoperatively
Secondary	Manifest refraction (Diopters)	Sphere, cylinder and axis of the manifest refraction will be recorded at follow ups	1 and 3 months postoperatively
Secondary	Defocus Curves (Diopters)	Defocus curves will be plotted by adding + and - lenses to the manifest refraction	1 and 3 months postoperatively
Secondary	Distance correct intermediate LogMAR visual acuity (DCIVA) at 60 cm	Uniocular and binocular best spectacle corrected intermediate vision will be recorded at follow ups	1 and 3 months postoperatively
Secondary	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	1 and 3 months postoperatively
Secondary	Quality of life outcomes assessment by the Catquest 9SF questionnaire	Patients will be requested to fill a questionnaire at all follow up visits	1 and 3 months postoperatively
Secondary	Glare and halos questionnaire on 1-4 Likert scale	(1= no glare and halos, 2= infrequent; 3 = frequent and 4 = continuous)	1 and 3 months postoperatively