Peripheral refraction with Eyhance versus Eyhance Pro intraocular lenses
| ISRCTN | ISRCTN17248590 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17248590 |
| Integrated Research Application System (IRAS) | 370734 |
| Central Portfolio Management System (CPMS) | 74165 |
| Sponsor | University Hospitals Sussex NHS Foundation Trust |
| Funder | Johnson and Johnson |
- Submission date
- 23/09/2026
- Registration date
- 13/10/2026
- Last edited
- 13/10/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
When cataract surgery is performed, the cloudy natural lens is replaced with an artificial lens called an intraocular lens (IOL). The TECNIS Eyhance IOL is an enhanced monofocal lens that provides excellent distance vision and improved intermediate vision (such as for computer use and cooking) compared to standard lenses. Johnson & Johnson has recently introduced a newer version called the TECNIS Eyhance Pro IOL, which is designed to additionally improve peripheral (side) vision while maintaining the same central vision quality. Both lenses are approved for routine NHS use and have excellent safety profiles.
This study aims to compare how these two lenses perform, particularly regarding peripheral vision. The study will recruit patients who need cataract surgery in both eyes. Each patient will receive one type of lens in one eye and the other type in the other eye (randomly allocated). This contralateral design eliminates differences between patients and allows direct comparison.
At one month after surgery, their peripheral vision will be measured using a specialised instrument (Grand Seiko WAM-5500 autorefractor), along with distance and intermediate vision, and ask patients about their visual experiences using questionnaires. The research assessments are entirely non-invasive and painless. This study will provide the first objective evidence of whether the newer Eyhance Pro lens truly offers advantages in peripheral vision compared to the standard Eyhance lens. The findings will inform lens selection for future cataract patients and advance understanding of how lens design influences peripheral visual performance
Who can participate?
Adults over 18 years old who require cataract surgery in both eyes.
What does the study involve?
Both eyes will be operated on the same day by experienced cataract surgeons. The surgery will be performed using the standard phacoemulsification technique (which uses ultrasound waves to break up and remove the cataract) with local anaesthesia (topical or sub-Tenon’s). A small incision will be made, the cataract removed, and the IOL implanted in the lens capsule. The surgical technique and safety profile are identical to those of standard NHS cataract surgery. Participants will have a follow-up at 1 month after their surgery where they will conduct some research tests including visual acuity testing (testing with one eye closed and the other open, for each eye separately), refraction (determining if they need glasses), peripheral refraction measurements (primary research assessment), clinical examination and questionnaires.
What are the possible benefits and risks of participating
Benefits:
Participants will receive two high-quality enhanced monofocal IOLs (either Eyhance or Eyhance Pro in each eye), both of which provide excellent distance vision and improved intermediate vision compared to standard monofocal lenses
• They will have thorough eye examinations at the 1-month research visit
• They will have the opportunity to directly compare two advanced lens technologies
• They may contribute to advancing knowledge that will benefit future cataract patients
The information obtained from this study will help:
• Determine whether the Eyhance Pro IOL offers measurable advantages in peripheral vision to improve peripheral visibility, which can help activities like driving and help patients with reduced central vision due to conditions like macular degeneration.
• Inform IOL selection and patient counselling for future cataract patients
• Advance our understanding of how IOL optical design influences peripheral visual performance
• Provide evidence for systematic reviews (comprehensive analyses of all available research evidence to guide medical practice) and clinical guidelines
Risks:
The general risks associated with any cataract surgery apply to this study. including:
• Infection (endophthalmitis): very rare, approximately 1 in 1,000-3,000 cases
• Inflammation
• Bleeding
• Retinal complications (such as retinal detachment)
• Cystoid macular oedema (swelling at the back of the eye)
• Posterior capsule opacification (clouding of the lens capsule requiring laser treatment)
• Corneal complications
• Refractive surprise (final glasses prescription different from target)
There are no additional surgical risks related to participating in this study. Both the Eyhance and Eyhance Pro IOLs are approved for NHS use and have excellent safety profiles identical to standard monofocal lenses.
Research-Related Risks
The research assessments (peripheral refraction measurements, iTrace scans, questionnaires) are:
• Non-invasive and painless
• Carry no additional risks
Where is the study run from?
Sussex Eye Hospital, UK.
When is the study starting and how long is it expected to run for?
The study is open to recruitment as of October 2026. Planned study end date is December 2027.
Who is funding the study?
Johnson & Johnson
Who is the main contact?
Professor Mayank Nanavaty, mayank.nanavaty@nhs.net
Contact information
Principal investigator, Scientific, Public
Consultant Ophthalmologist, Sussex Eye Hospital Eastern Road
Brighton
BN2 5BF
United Kingdom
 ORCID ID |
0000-0003-0667-3700 |
|---|---|
| Phone | +44 (0)1273 696955 |
| mayank.nanavaty@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Prospective, randomised, contralateral comparative study of peripheral refraction after implantation of an enhanced monofocal and an enhanced monofocal with improved peripheral vision intraocular lenses |
| Study objectives | Primary: To compare peripheral astigmatism profiles at 20° horizontal nasal eccentricities between eyes implanted with TECNIS Eyhance IOL and TECNIS Eyhance Pro IOL using Grand Seiko WAM-5500 autorefractometry at 1 month postoperatively Secondary: 1. Compare peripheral blur and astigmatism at 30° nasal, 20° and 30° temporal 2. Compare monocular UCDVA at 4m 3. Compare monocular BCDVA at 4m 4. Compare monocular UCIVA at 66cm 5. Compare monocular DCIVA at 66cm 6. Assess patient-reported visual function and symptoms 7. Determine patient preference 8. Assess central wavefront aberrations (iTrace, 5mm pupil) 9. Document adverse events |
| Ethics approval(s) |
Approved 21/09/2026, London - Surrey Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; surrey.rec@hra.nhs.uk), ref: 26/PR/0818 |
| Health condition(s) or problem(s) studied | Disorders of lens |
| Intervention | This is a prospective, randomised study comparing two intraocular lenses (TECNIS Eyhance and TECNIS Eyhance Pro) in patients having cataract surgery on both eyes. Before Surgery: Patients will undergo standard NHS cataract assessments (no additional research procedures). Eligible patients will be given information about the study and asked to provide consent. On Surgery Day: A computer will randomly assign which lens goes in which eye. Both eyes will be operated on the same day by experienced cataract surgeons using the standard surgical technique (phacoemulsification). The surgery is identical to routine NHS cataract surgery. One Month After Surgery (Research Visit, approximately 60-75 minutes): - Vision testing for each eye separately (distance at 4 metres and intermediate at 66 cm) - Glasses prescription check - Peripheral vision measurements using the Grand Seiko autorefractor at various angles (central, 20° and 30° nasal and temporal). This involves sitting with the head stabilised while the instrument takes automatic readings. This is completely painless and non-invasive, taking approximately 15-20 minutes. - iTrace scan to measure optical quality (a few seconds per eye, non-invasive) - Standard clinical eye examination - Questionnaire about visual function, symptoms, satisfaction, and preference (10-15 minutes) Patients are masked (they do not know which lens is in which eye). The person measuring vision is also masked. After the 1-month visit, participation in the study is complete. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Intraocular lenses |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 32 |
| Key inclusion criteria | 1. Adults aged 18 years and over 2. Bilateral cataracts scheduled for routine cataract surgery on both eyes 3. Potential for good postoperative visual acuity (no significant ocular comorbidity) 4. Able to provide written informed consent 5. Able to attend the research follow-up visit at 1 month postoperatively. |
| Key exclusion criteria | 1. Amblyopia (lazy eye) 2. Eyes with any ocular comorbidity with cornea, uvea, retina or optic nerve, which may be detrimental to visual outcomes 3. Previous ocular refractive surgery |
| Date of first enrolment | 07/10/2026 |
| Date of final enrolment | 01/12/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Worthing
BN11 2AA
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
23/09/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
