CataractNCT04122664
Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses
A study testing RayOne® Hydrophobic lens 800C and RayOne® Hydrophilic lens 600C in people with Cataract and Intraocular Lens Opacification, run by Guy's and St Thomas' NHS Foundation Trust.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Intraocular Lens Opacification
- What is being tested?
- RayOne® Hydrophobic lens 800C and RayOne® Hydrophilic lens 600C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2019to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
- any inherited retinal disorder or pathology
Show all 9Show fewer
- previous strabismus surgery or record of amblyopia
- previous TIA, CVA or other vaso-occlusive disease
- already enrolled in another study
Trial locations and contacts
No sites are listed yet.
About this study
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.
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
- Conditions
- Cataract, Intraocular Lens Opacification
- Being tested
- RayOne® Hydrophobic lens 800C, RayOne® Hydrophilic lens 600C
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RayOne® Hydrophobic lens 800CDevice
Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C
RayOne® Hydrophilic lens 600CDevice
Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.
| Study group | Role | What they receive |
|---|---|---|
| RayOne® Hydrophilic lens 600C | Active comparator | Patients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C Receives: 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 Receives: Device: RayOne® Hydrophobic lens 800C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Capsular Opacification of Intraocular Lens
Degree of the Posterior Capsular Opacification of Intraocular Lens will be assessed using digital imaging techniques
Measured: 24 months
Intraocular lens glistenings
Degree of the intraocular lens glistenings will be quantified using digital analysis
Measured: 24 months
Intraocular lens tilt and decentration
Measured: 24 months
Secondary outcomes (4)
Visual Acuities
Unaided and Best corrected Logmar Visual acuity for distance, and for near vision will be assessed
Measured: 24 months
Forward light scatter and Contrast Sensitivity Measurement
Forward light scatter and Contrast Sensitivity Measurement will be quantified using computerised visual testing
Measured: 24 months
Patient Satisfaction
Validated questionnaires will be used to assess patient satisfaction
Measured: 24 months
Intraoperative and post operative complications
Measured: 0 days-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start14 Oct 2019 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122664
- Sponsor's protocol ID
- 265864
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04122664
- Acronym / sponsor ID
- 265864
- Conditions
- Cataract, Intraocular Lens Opacification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- City, University of London, King's College London
- Study start
- 14 Oct 2019 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RayOne® Hydrophilic lens 600C | Active comparator | Device: RayOne® Hydrophilic lens 600CPatients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophilic lens 600C |
| RayOne® Hydrophobic lens 800C | Active comparator | Device: RayOne® Hydrophobic lens 800CPatients will be randomly selected to receive the monofocal, acrylic, RayOne® Hydrophobic lens 800C |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RayOne® Hydrophobic lens 800CPatients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C | Device | RayOne® Hydrophobic lens 800C |
| RayOne® Hydrophilic lens 600CPatients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C. | Device | RayOne® Hydrophilic lens 600C |
Primary outcome
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
Intraocular lens glistenings
Time frame: 24 months
Degree of the intraocular lens glistenings will be quantified using digital analysis
Intraocular lens tilt and decentration
Time frame: 24 months
4 secondary outcomes
Visual Acuities
Time frame: 24 months
Forward light scatter and Contrast Sensitivity Measurement
Time frame: 24 months
Patient Satisfaction
Time frame: 24 months
Intraoperative and post operative complications
Time frame: 0 days-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing RayOne® Hydrophobic lens 800C and RayOne® Hydrophilic lens 600C in people with Cataract and Intraocular Lens Opacification, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khayam Naderi, MBBS BSc MA (020 7188 7188 ext. 84331, khayam.naderi@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior Capsular Opacification of Intraocular Lens (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.