Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Study Overview
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Brief Summary
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A prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C and a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C

Official Title
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Prospective Randomized Controlled Study Measuring Posterior Capsular Opacification, Lens Glistenings, Tilt and Decentration, and Visual Outcomes Following Insertion of the RayOne Hydrophobic Lens 800C and the RayOne Hydrophilic Lens 600C.

Conditions
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Cataract, Intraocular Lens Opacification

Intervention / Treatment
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* Device: RayOne® Hydrophobic lens 800C
* Device: RayOne® Hydrophilic lens 600C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral cataracts requiring surgical intervention Age over 18 years Able to understand informed consent and the objectives of the trial Not pregnant, not breast feeding No previous eye surgery Corneal astigmatism less than 1 diopter in both eyes. Exclusion Criteria: age-related macula degeneration glaucoma previous retinal vascular disorders previous retinal detachment or tear any neuro-ophthalmological condition any inherited retinal disorder or pathology previous strabismus surgery or record of amblyopia previous TIA, CVA or other vaso-occlusive disease already enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RayOne® Hydrophilic lens 600C<br>Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C | Device: RayOne® Hydrophilic lens 600C<br>* Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.<br>|
| Active Comparator: RayOne® Hydrophobic lens 800C<br>Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C | Device: RayOne® Hydrophobic lens 800C<br>* Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior Capsular Opacification of Intraocular Lens | Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques | 24 months | 
| Intraocular lens glistenings | Degree of the intraocular lens glistenings will be quantified using digital analysis | 24 months | 
| Intraocular lens tilt and decentration |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuities | Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed | 24 months | 
| Forward light scatter and Contrast Sensitivity Measurement | Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing | 24 months | 
| Patient Satisfaction | Validated questionnaires will be used to assess patient satisfaction | 24 months | 
| Intraoperative and post operative complications |  | 0 days-24 months |