Clincosm LogoSign in Get a demo

Visual Performance With a Hydrophobic Aspheric Monofocal IOL

Sponsor
University of Plymouth (Other)
Overall Status
Unknown status
CT.gov ID
NCT03819582
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
23
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Visual acuity early post operative [1 month post operatively]

    Visual acuity measured in LogMAR early post operatively

  2. Visual acuity after 3 months post operatively [3 months post operatively]

    Visual acuity measured in LogMAR measured 3 months post operatively

Secondary Outcome Measures

  1. Ease of use to surgeons [During surgery]

    Questionnaire completed by the surgeon to determine the usability of the intraocular lens

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 BMI Southend Hospital Westcliff-on-Sea Essex United Kingdom SS0 9AG

Sponsors and Collaborators

  • University of Plymouth

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 28, 2019
Last Update Posted:
Jan 28, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jan 28, 2019