Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Not Applicable

• Conditions: Intraocular Lens Opacification; Cataract
• Interventions: Device: RayOne® Hydrophilic lens 600C; Device: RayOne® Hydrophobic lens 800C

• Registration Number: NCT04122664
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10
• Study Start: 2019-10-14
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. Unilateral or bilateral cataracts requiring surgical intervention
2. Age over 18 years
3. Able to understand informed consent and the objectives of the trial
4. Not pregnant, not breast feeding
5. No previous eye surgery
6. Corneal astigmatism less than 1 diopter in both eyes.

Exclusion Criteria

1. age-related macula degeneration
2. glaucoma
3. previous retinal vascular disorders
4. previous retinal detachment or tear
5. any neuro-ophthalmological condition
6. any inherited retinal disorder or pathology
7. previous strabismus surgery or record of amblyopia
8. previous TIA, CVA or other vaso-occlusive disease
9. already enrolled in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RayOne® Hydrophilic lens 600C	RayOne® Hydrophilic lens 600C	Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C
RayOne® Hydrophobic lens 800C	RayOne® Hydrophobic lens 800C	Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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