NCT04122664

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2.5 years

First QC Date

October 8, 2019

Last Update Submit

October 9, 2019

Conditions

CataractIntraocular Lens Opacification

Outcome Measures

Primary Outcomes (3)

  • Posterior Capsular Opacification of Intraocular Lens

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

    24 months

  • Intraocular lens glistenings

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

    24 months

  • Intraocular lens tilt and decentration

    24 months

Secondary Outcomes (4)

  • Visual Acuities

    24 months

  • Forward light scatter and Contrast Sensitivity Measurement

    24 months

  • Patient Satisfaction

    24 months

  • Intraoperative and post operative complications

    0 days-24 months

Study Arms (2)

RayOne® Hydrophilic lens 600C

ACTIVE COMPARATOR

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

Device: RayOne® Hydrophilic lens 600C

RayOne® Hydrophobic lens 800C

ACTIVE COMPARATOR

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

Device: RayOne® Hydrophobic lens 800C

Interventions

RayOne® Hydrophobic lens 800CDEVICE

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

RayOne® Hydrophobic lens 800C
RayOne® Hydrophilic lens 600CDEVICE

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

RayOne® Hydrophilic lens 600C

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral or bilateral cataracts requiring surgical intervention
  • Age over 18 years
  • Able to understand informed consent and the objectives of the trial
  • Not pregnant, not breast feeding
  • No previous eye surgery
  • Corneal astigmatism less than 1 diopter in both eyes.

You may not qualify if:

  • age-related macula degeneration
  • glaucoma
  • previous retinal vascular disorders
  • previous retinal detachment or tear
  • any neuro-ophthalmological condition
  • any inherited retinal disorder or pathology
  • previous strabismus surgery or record of amblyopia
  • previous TIA, CVA or other vaso-occlusive disease
  • already enrolled in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Khayam Naderi, MBBS BSc MA

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients randomised into one of two groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

October 14, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share