Patient consent form

IRAS ID

366611

Study Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Chief Investigator

Vincenzo Maurino

Researchers

Gabriele Gallo Afflitto & Chris Leak

Participant ID

Consent statements

Please 

initial

1.

I confirm that I have read and understood the information sheet dated 04 March 2026 v2.0 for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.

2.

I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.

3.

I understand that this study compares two different multifocal intraocular lenses (IOLs) used in cataract surgery: the Alcon Clareon PanOptix IOL and the Rayner Galaxy Spiral IOL. Both lenses are CE-marked, commercially available, and routinely used in private practice to help patients achieve greater independence from glasses. The aim of this study is to compare visual outcomes, spectacle independence, and the frequency of unwanted visual effects such as glare, haloes, or starbursts (collectively known as dysphotopsia). The assignment to either lens group will be determined by randomisation (like the flip of a coin), and neither I nor the clinical team assessing my vision will know which lens has been implanted. The surgeon performing the procedure will know the lens type for technical reasons, but this information will not be shared with me or the assessors until the end of the study.

4.

I understand that I am being invited to take part because I have cataracts in both eyes and require surgery in both eyes. My eyes are otherwise healthy, with no other ocular conditions that could affect vision. I wish to reduce my dependence on glasses following cataract surgery.

5.

I understand that my surgery and follow-up will follow the same high standards as in routine NHS or private cataract surgery. I will attend several routine pre- and post-operative visits as part of my usual care and a few additional research visits at Moorfields Eye Hospital. I will also be asked to complete short questionnaires about my vision and quality of life after surgery.

6.

I understand that both IOLs are already in regular use and approved for implantation in cataract surgery. Taking part may help me achieve greater independence from glasses, but this cannot be guaranteed.

Possible side effects of multifocal IOLs include:

• Glare, haloes, or starbursts around lights.

• Reduced contrast sensitivity, particularly in dim light.

• Possible need for glasses for some activities even after surgery.

• Usual surgical risks such as infection, inflammation, or retinal detachment, which are rare but recognised.

7.

If I have astigmatism, this may be corrected during surgery either by corneal relaxing incisions or by implanting a toric intraocular lens (T-IOL), both of which are standard techniques in routine cataract surgery. In some cases, a small spectacle correction or an additional enhancement procedure may be needed to achieve optimal vision. In approximately 1 in 100 cases where a T-IOL is used, a second minor operation to reposition the lens may be required to obtain the best visual result.

8.

I understand that relevant sections of any of my medical notes and data collected during the study may be looked at by responsible individuals from this Hospital, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records.

9.

I give permission for the use of pictures of my eyes for publication and/or presentation purposes.

10.

I give permission for my GP to be informed about my participation in this study.

11.

I understand that the intraocular lens (IOL) to be implanted during the surgery is a regulated medical device manufactured by an independent company. While the surgeon and the hospital take all reasonable care in the selection and implantation of the IOL, they do not manufacture the device and cannot guarantee its long-term performance. Any defect, opacification, malfunction, or failure of the IOL is the responsibility of the manufacturer. I acknowledge that my surgeon and hospital cannot be held liable for faults inherent in the IOL as a manufactured product. This does not affect any statutory rights I may have under UK law in relation to the manufacturer or supplier of a medical device. Moorfields as an NHS hospital will always in NHS settings (not within Moorfields Private) be able to help you and perform remedial surgery even if the implant becomes faulty (e.g. opaque) decades later but this type of surgery will beoffered only by Moorfields NHS and upon referral from your GP if deemed necessary and possible.

12.

I give permission for a member of the research team to contact me by telephone before ordering the lenses for my operation, to confirm that I am still willing to take part in this study.

13.

I consent to the use of specific data collected retrospectively about me as part of my clinical care such as physical exam, vital signs, visual acuity, manifest refraction, biometry, total Keratometry, and ACD measurements, to be utilized for analysis in this study.

14.

I agree to take part in the above study.