- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122664
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Khayam Naderi, MBBS BSc MA
- Phone Number: 84331 020 7188 7188
- Email: khayam.naderi@gstt.nhs.uk
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:
- 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.
Exclusion Criteria:
- 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
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.
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