Visual Performance With a Hydrophobic Aspheric Monofocal IOL
Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 28, 2019
January 1, 2019
1.8 years
January 22, 2019
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Visual acuity early post operative
Visual acuity measured in LogMAR early post operatively
1 month post operatively
Visual acuity after 3 months post operatively
Visual acuity measured in LogMAR measured 3 months post operatively
3 months post operatively
Secondary Outcomes (1)
Ease of use to surgeons
During surgery
Study Arms (1)
Intraocular lens
EXPERIMENTALSubjects implanted with the EyeCee One Intraocular lens
Interventions
Eligibility Criteria
You may qualify if:
- Clinically significant Cataract requiring cataract surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BMI Southend Hospital
Westcliff-on-Sea, Essex, SS0 9AG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Head of School for Research
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 28, 2019
Study Start
February 1, 2018
Primary Completion
December 1, 2019
Study Completion
January 1, 2020
Last Updated
January 28, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share