Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

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.

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

Study Overview

• Status: Unknown
• Conditions: Cataract; Intraocular Lens Opacification
• Intervention / Treatment: Device: RayOne® Hydrophilic lens 600C; Device: RayOne® Hydrophobic lens 800C

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; City, University of London

Study record dates

Study Major Dates

• Study Start (Anticipated): October 14, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: 265864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No