Visual Performance With a Hydrophobic Aspheric Monofocal IOL

Study Overview
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Brief Summary
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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
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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.

Official Title
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Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: EyeCee One intraocular lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraocular lens<br>Subjects implanted with the EyeCee One Intraocular lens | Device: EyeCee One intraocular lens<br>* Hydrophobic aspheric monofocal intraocular lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use to surgeons | Questionnaire completed by the surgeon to determine the usability of the intraocular lens | During surgery |