Evaluation of the Eyhance and Zoe Lenses
ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity Hospital Plymouth NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Monofocal IOL group
Trial outcomes
Primary outcomes
1
Visual acuity
To assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs)
Time frame
From enrollment to the clinical assessment at 3 monthsSecondary outcomes
1
Depth of focus
To assess depth of focus of the IOLs
Time frame
From enrollment to the clinical assessment at 3 months2
Tilt
To assess tilt of the IOLs
Time frame
From enrollment to the clinical assessment at 3 months3
Decentration
To assess decentration of the IOLs
Time frame
From enrollment to the postoperative visit at 3 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Plymouth NHS Trust
Lead sponsor
Southend NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: