Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses

October 9, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust

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.

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 Overview

Study Type

Interventional

Enrollment (Anticipated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RayOne® Hydrophilic lens 600C
Patients will be randomly selected to receive the monofocal, acrylic, 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
Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posterior Capsular Opacification of Intraocular Lens
Time Frame: 24 months
Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques
24 months
Intraocular lens glistenings
Time Frame: 24 months
Degree of the intraocular lens glistenings will be quantified using digital analysis
24 months
Intraocular lens tilt and decentration
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuities
Time Frame: 24 months
Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed
24 months
Forward light scatter and Contrast Sensitivity Measurement
Time Frame: 24 months
Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing
24 months
Patient Satisfaction
Time Frame: 24 months
Validated questionnaires will be used to assess patient satisfaction
24 months
Intraoperative and post operative complications
Time Frame: 0 days-24 months
0 days-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 14, 2019

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 265864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on RayOne® Hydrophilic lens 600C

3
Subscribe