Cataract
Conditions
Brief summary
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.
Detailed description
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon. Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation). At both post-operative visits the patient will undergo: Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.
Interventions
DEVICEEyeCee One intraocular lens
Hydrophobic aspheric monofocal intraocular lens
Sponsors
University of Plymouth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
-Clinically significant Cataract requiring cataract surgery
Exclusion criteria
* Amblyopia * Corneal astigmatism of \>1.00D * Dilated pupil size smaller than 5mm * Macular pathology * Glaucoma * Retinal disease * Corneal disease * Abnormal iris * Pupil deformation * Any previous corneal or intraocular surgery * Any patient who had surgical complications will also be excluded from participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity early post operative | 1 month post operatively | Visual acuity measured in LogMAR early post operatively |
| Visual acuity after 3 months post operatively | 3 months post operatively | Visual acuity measured in LogMAR measured 3 months post operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use to surgeons | During surgery | Questionnaire completed by the surgeon to determine the usability of the intraocular lens |
Countries
United Kingdom
Contacts
Primary ContactPhillip Buckhurst
Outcome results
None listed