A Phase 4 interventional study of EyeCee One intraocular lens in Cataract, sponsored by University of Plymouth. Status unknown at 1 site in United Kingdom. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-01-28.
Sponsored by University of Plymouth · Phase 4, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →University of Plymouth is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
-Clinically significant Cataract requiring cataract surgery
Exclusion Criteria:
Subjects implanted with the EyeCee One Intraocular lens
Device: EyeCee One intraocular lens
Hydrophobic aspheric monofocal intraocular lens
Visual acuity early post operative
Visual acuity measured in LogMAR early post operatively
Time frame: 1 month post operatively
Visual acuity after 3 months post operatively
Visual acuity measured in LogMAR measured 3 months post operatively
Time frame: 3 months post operatively
Ease of use to surgeons
Questionnaire completed by the surgeon to determine the usability of the intraocular lens
Time frame: During surgery
Plan to share: No
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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University of Plymouth