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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04122664
Other study ID # 265864
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date May 2022

Study information

Verified date October 2019
Source Guy's and St Thomas' NHS Foundation Trust
Contact Khayam Naderi, MBBS BSc MA
Phone 020 7188 7188
Email khayam.naderi@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 176
Est. completion date May 2022
Est. primary completion date May 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Intervention

Device:
RayOne® Hydrophobic lens 800C
Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C
RayOne® Hydrophilic lens 600C
Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust City, University of London, King's College London

Outcome

Type Measure Description Time frame Safety issue
Primary Posterior Capsular Opacification of Intraocular Lens Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques 24 months
Primary Intraocular lens glistenings Degree of the intraocular lens glistenings will be quantified using digital analysis 24 months
Primary Intraocular lens tilt and decentration 24 months
Secondary Visual Acuities Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed 24 months
Secondary Forward light scatter and Contrast Sensitivity Measurement Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing 24 months
Secondary Patient Satisfaction Validated questionnaires will be used to assess patient satisfaction 24 months
Secondary Intraoperative and post operative complications 0 days-24 months
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