Visual Performance With a Hydrophobic Aspheric Monofocal IOL

NCT ID: NCT03819582

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-01-01

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraocular lens

Subjects implanted with the EyeCee One Intraocular lens

Group Type: EXPERIMENTAL

EyeCee One intraocular lens

Intervention Type: DEVICE

Hydrophobic aspheric monofocal intraocular lens

Interventions

EyeCee One intraocular lens

Hydrophobic aspheric monofocal intraocular lens

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Plymouth

OTHER

Sponsor Role: lead

Responsible Party

Dr Phillip J Buckhurst

Associate Head of School for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BMI Southend Hospital

Westcliff-on-Sea, Essex, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Phillip Buckhurst

Role: CONTACT

phillip.buckhurst@plymouth.ac.uk

07825429121

Facility Contacts

Elizabeth Law

Role: primary

elizabeth.law@plymouth.ac.uk

Other Identifiers

17/WM/0181

Identifier Type: -

Identifier Source: org_study_id