Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: RayOne® Hydrophilic lens 600C Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C |
Device: RayOne® Hydrophilic lens 600C
Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.
|
Active Comparator: RayOne® Hydrophobic lens 800C Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C |
Device: RayOne® Hydrophobic lens 800C
Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C
|
Outcome Measures
Primary Outcome Measures
- Posterior Capsular Opacification of Intraocular Lens [24 months]
Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques
- Intraocular lens glistenings [24 months]
Degree of the intraocular lens glistenings will be quantified using digital analysis
- Intraocular lens tilt and decentration [24 months]
Secondary Outcome Measures
- Visual Acuities [24 months]
Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed
- Forward light scatter and Contrast Sensitivity Measurement [24 months]
Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing
- Patient Satisfaction [24 months]
Validated questionnaires will be used to assess patient satisfaction
- Intraoperative and post operative complications [0 days-24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unilateral or bilateral cataracts requiring surgical intervention
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Age over 18 years
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Able to understand informed consent and the objectives of the trial
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Not pregnant, not breast feeding
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No previous eye surgery
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Corneal astigmatism less than 1 diopter in both eyes.
Exclusion Criteria:
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age-related macula degeneration
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glaucoma
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previous retinal vascular disorders
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previous retinal detachment or tear
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any neuro-ophthalmological condition
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any inherited retinal disorder or pathology
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previous strabismus surgery or record of amblyopia
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previous TIA, CVA or other vaso-occlusive disease
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already enrolled in another study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- City, University of London
- King's College London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 265864