Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Cataract Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04122664
• Other study ID #: 265864
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Intraocular Lens Opacification

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