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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04122664

Enrollment

176

Registered

2019-10-10

Start date

2019-10-14

Completion date

2022-05-31

Last updated

2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Intraocular Lens Opacification

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

Interventions

DEVICERayOne® Hydrophobic lens 800C

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

DEVICERayOne® Hydrophilic lens 600C

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Patients randomised into one of two groups

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Visual Acuities	24 months	Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed
Intraoperative and post operative complications	0 days-24 months	—
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

Contacts

Primary ContactKhayam Naderi, MBBS BSc MA

khayam.naderi@gstt.nhs.uk020 7188 7188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026