Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT04122664
Collaborator
City, University of London (Other), King's College London (Other)
176
2
30.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: RayOne® Hydrophobic lens 800C
  • Device: RayOne® Hydrophilic lens 600C
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Patients randomised into one of two groups
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Oct 14, 2019
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: RayOne® Hydrophilic lens 600C

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

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

Active Comparator: RayOne® Hydrophobic lens 800C

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

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

Outcome Measures

Primary Outcome Measures

  1. Posterior Capsular Opacification of Intraocular Lens [24 months]

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

  2. Intraocular lens glistenings [24 months]

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

  3. Intraocular lens tilt and decentration [24 months]

Secondary Outcome Measures

  1. Visual Acuities [24 months]

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

  2. Forward light scatter and Contrast Sensitivity Measurement [24 months]

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

  3. Patient Satisfaction [24 months]

    Validated questionnaires will be used to assess patient satisfaction

  4. Intraoperative and post operative complications [0 days-24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04122664
Other Study ID Numbers:
  • 265864
First Posted:
Oct 10, 2019
Last Update Posted:
Oct 10, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2019