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Visual Performance With a Hydrophobic Aspheric Monofocal IOL

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ClinicalTrials.gov Identifier: NCT03819582
Recruitment Status : Unknown
Verified January 2019 by Dr Phillip J Buckhurst, University of Plymouth.
Recruitment status was:  Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Phillip J Buckhurst, University of Plymouth

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Device: EyeCee One intraocular lens Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intraocular lens
Subjects implanted with the EyeCee One Intraocular lens
 Device: EyeCee One intraocular lens
Hydrophobic aspheric monofocal intraocular lens


Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity early post operative [ Time Frame: 1 month post operatively ]
    Visual acuity measured in LogMAR early post operatively

  2. Visual acuity after 3 months post operatively [ Time Frame: 3 months post operatively ]
    Visual acuity measured in LogMAR measured 3 months post operatively


Secondary Outcome Measures :
  1. Ease of use to surgeons [ Time Frame: During surgery ]
    Questionnaire completed by the surgeon to determine the usability of the intraocular lens


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819582


Contacts
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Contact: Phillip Buckhurst 07825429121 phillip.buckhurst@plymouth.ac.uk

Locations
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United Kingdom
BMI Southend Hospital Recruiting
Westcliff-on-Sea, Essex, United Kingdom, SS0 9AG
Contact: Elizabeth Law       elizabeth.law@plymouth.ac.uk   
Sponsors and Collaborators
University of Plymouth
More Information
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Responsible Party: Dr Phillip J Buckhurst, Associate Head of School for Research, University of Plymouth
ClinicalTrials.gov Identifier: NCT03819582    
Other Study ID Numbers: 17/WM/0181
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases