Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Cataract; Intraocular Lens Opacification

Treatments: Device: RayOne® Hydrophobic lens 800C; Device: RayOne® Hydrophilic lens 600C

Study type: Interventional

Funder types: Other

Identifiers

NCT04122664

265864

Details and patient eligibility

About

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

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

RayOne® Hydrophilic lens 600C

Active Comparator group

Description:

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

Treatment:

Device: RayOne® Hydrophilic lens 600C

RayOne® Hydrophobic lens 800C

Active Comparator group

Description:

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

Treatment:

Device: RayOne® Hydrophobic lens 800C