Visual Performance With a Hydrophobic Aspheric Monofocal IOL
Primary Purpose
Cataract
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
EyeCee One intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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.
Sites / Locations
- BMI Southend HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraocular lens
Arm Description
Subjects implanted with the EyeCee One Intraocular lens
Outcomes
Primary Outcome Measures
Visual acuity early post operative
Visual acuity measured in LogMAR early post operatively
Visual acuity after 3 months post operatively
Visual acuity measured in LogMAR measured 3 months post operatively
Secondary Outcome Measures
Ease of use to surgeons
Questionnaire completed by the surgeon to determine the usability of the intraocular lens
Full Information
NCT ID
NCT03819582
First Posted
January 22, 2019
Last Updated
January 24, 2019
Sponsor
University of Plymouth
1. Study Identification
Unique Protocol Identification Number
NCT03819582
Brief Title
Visual Performance With a Hydrophobic Aspheric Monofocal IOL
Official Title
Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraocular lens
Arm Type
Experimental
Arm Description
Subjects implanted with the EyeCee One Intraocular lens
Intervention Type
Device
Intervention Name(s)
EyeCee One intraocular lens
Intervention Description
Hydrophobic aspheric monofocal intraocular lens
Primary Outcome Measure Information:
Title
Visual acuity early post operative
Description
Visual acuity measured in LogMAR early post operatively
Time Frame
1 month post operatively
Title
Visual acuity after 3 months post operatively
Description
Visual acuity measured in LogMAR measured 3 months post operatively
Time Frame
3 months post operatively
Secondary Outcome Measure Information:
Title
Ease of use to surgeons
Description
Questionnaire completed by the surgeon to determine the usability of the intraocular lens
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip Buckhurst
Phone
07825429121
Email
phillip.buckhurst@plymouth.ac.uk
Facility Information:
Facility Name
BMI Southend Hospital
City
Westcliff-on-Sea
State/Province
Essex
ZIP/Postal Code
SS0 9AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Law
Email
elizabeth.law@plymouth.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visual Performance With a Hydrophobic Aspheric Monofocal IOL
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