Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

NCT ID: NCT04122664

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2022-05-31

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

Detailed Description

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Conditions

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Cataract Intraocular Lens Opacification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients randomised into one of two groups

Study Groups

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RayOne® Hydrophilic lens 600C

Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C

Group Type ACTIVE_COMPARATOR

RayOne® Hydrophilic lens 600C

Intervention Type DEVICE

Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.

RayOne® Hydrophobic lens 800C

Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C

Group Type ACTIVE_COMPARATOR

RayOne® Hydrophobic lens 800C

Intervention Type DEVICE

Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C

Interventions

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RayOne® Hydrophobic lens 800C

Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C

Intervention Type DEVICE

RayOne® Hydrophilic lens 600C

Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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City, University of London

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Khayam Naderi, MBBS BSc MA

Role: CONTACT

020 7188 7188 ext. 84331

Other Identifiers

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265864

Identifier Type: -

Identifier Source: org_study_id

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