Evaluation of the Eyhance and Zoe Lenses

NCT06665659 | Not Yet Recruiting

• 1 other identifier: 345720
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs). The main outcomes are: To assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs) To assess depth of focus of the IOLs To assess tilt and decentration of the IOLs The potential participants will be chosen from the list of patients in the Southend NHS database who have had routine cataract surgery using the Zoe or Eyhance lenses in the past 12 months and contacted by phone and letter. The member of the ophthalmological team carrying out the screening will use the research inclusion and exclusion criteria to identify 50 potential participants. Once identified, the potential participants will be asked if they would be willing to discuss inclusion into the study with a member of the clinical care team (Prof Myerscough or Dr Law). If they agree, they will be asked to attend one further clinical visit. They will be given a patient information sheet and consent form at this visit. All potential participants will be informed that participation in this research study will be entirely voluntary. At the clinical visit participants will have their vision assessed, have dilating drops instilled, and undergo two non-invasive scans of their eyes.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  To assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs)

  From enrollment to the clinical assessment at 3 months

Secondary Outcomes (3)

• Depth of focus

  From enrollment to the clinical assessment at 3 months

• Tilt

  From enrollment to the clinical assessment at 3 months

• Decentration

  From enrollment to the postoperative visit at 3 months

Study Arms (1)

Monofocal IOL group

Participants who have had either the Tecnis Eyhance or OphthalmoPro Zoe monofocal lens implanted during routine cataract surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both the Tecnis Eyhance and OphthalmoPro Zoe are monofocal lenses approved for use in patients having routine cataract surgery and are available in the Southend Eye Clinic lens bank. Of these patients 50 participants who have had routine cataract surgery with one of these lenses within the past 12 months will be chosen. Patients will be identified from the Southend NHS database. The database search will be carried out by the clinical care team. Potential participants will be asked to come to the eye clinic for one additional follow up visit in which they will have vision assessed in the operated eye(s). Potential participants will be contacted by phone and by letter.

You may qualify if:

• Adult (over 18) patients with cataract requiring cataract surgery with phacoemulsification and intraocular lens implantation.
• Patients who have had either an OphthalmoPro Zoe or a Tecnis Eyhance monofocal lens implanted during routine cataract surgery within the past year

You may not qualify if:

• Previous penetrating keratoplasty or anterior lamellar keratoplasty
• Patients who are not willing to cooperate for the follow up period
• Patients where it is not possible to take informed consent

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead
• Southend NHS Foundation Trust: collaborator

Related Publications (2)

• Lapp T, Wacker K, Heinz C, Maier P, Eberwein P, Reinhard T. Cataract Surgery-Indications, Techniques, and Intraocular Lens Selection. Dtsch Arztebl Int. 2023 May 30;120(21):377-386. doi: 10.3238/arztebl.m2023.0028.

  PMID: 36794457 BACKGROUND

• Kanclerz P, Toto F, Grzybowski A, Alio JL. Extended Depth-of-Field Intraocular Lenses: An Update. Asia Pac J Ophthalmol (Phila). 2020 May-Jun;9(3):194-202. doi: 10.1097/APO.0000000000000296.

  PMID: 32511121 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Phillip Buckhurst, PhD

  Plymouth University

  STUDY DIRECTOR

Central Study Contacts

James Myerscough, MBBS

CONTACT

+44 1702435555; james.myerscough1@nhs.net

Poonam Sharma, MBBS

CONTACT

+44 7921661425; poonam.sharma7@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: October 30, 2024
• Study Start: November 30, 2024
• Primary Completion: August 29, 2025
• Study Completion: December 31, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share