Visual Performance With a Hydrophobic Aspheric Monofocal IOL

Phase 4

• Conditions: Cataract
• Interventions: Device: EyeCee One intraocular lens

• Registration Number: NCT03819582
• Lead Sponsor: University of Plymouth

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.

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Last Update Submitted: 2019-01-24
• Study First Posted: 2019-01-28
• Last Update Posted: 2019-01-28
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraocular lens	EyeCee One intraocular lens	Subjects implanted with the EyeCee One Intraocular lens

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Ease of use to surgeons	During surgery	Questionnaire completed by the surgeon to determine the usability of the intraocular lens

Trial Locations

Locations (1)

BMI Southend Hospital; 🇬🇧 Westcliff-on-Sea, Essex, United Kingdom