Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Guy's and St Thomas' NHS Foundation Trust176 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

176

Conditions

Cataract Intraocular Lens Opacification

Interventions

RayOne® Hydrophobic lens 800CDEVICE

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

RayOne® Hydrophilic lens 600CDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Posterior Capsular Opacification of Intraocular Lens

Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques

Time frame: 24 months

Intraocular lens glistenings

Degree of the intraocular lens glistenings will be quantified using digital analysis

Time frame: 24 months

Intraocular lens tilt and decentration

Time frame: 24 months

Secondary Outcomes

Visual Acuities

Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed

Time frame: 24 months

Forward light scatter and Contrast Sensitivity Measurement

Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing

Time frame: 24 months

Patient Satisfaction

Validated questionnaires will be used to assess patient satisfaction

Time frame: 24 months

Intraoperative and post operative complications

Time frame: 0 days-24 months

Central Contacts

Khayam Naderi, MBBS BSc MA

CONTACT

020 7188 7188 khayam.naderi@gstt.nhs.uk

Data from ClinicalTrials.gov

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