CataractNCT02378636
Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
A study testing 600S in people with Cataract, run by Rayner Intraocular Lenses Limited at 1 site in United Kingdom.
Trial summary
This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- 600S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Aug 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥21 years of age.
- Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
- Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
- Calculated IOL power requirement within the range +8.0 to +34.0D
- If present, subject must have corneal astigmatism of <1.50 D in the operative eye.
- Expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings
- Subject must provide written informed consent.
- Subject must be able to return for scheduled follow-up examinations for 24 months after surgery.
Who cannot join
- History of ocular trauma or prior ocular surgery in the operative eye.
- Microphthalmia
- Corneal decompensation or endothelial insufficiency
- Pseudo exfoliation
- Pars planitis
- Subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logMAR) or worse.
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- Inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag
- Active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma.
- Concurrent participation in another drug or device investigation.
- Patients who are expected to require retinal laser treatment.
- Females who are pregnant, nursing or plan to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Contact Rayner Intraocular Lenses Limited for Locations
Hove, East Sussex, BN3 7AN
About this study
This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.
- Conditions
- Cataract
- Being tested
- 600S
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600SDevice
Also called Modified 600C (axis marks)
Monofocal Aspheric Intraocular Lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| 600S | Experimental | Modified 600C (axis marks) monofocal aspheric intraocular lens Receives: Device: 600S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Distance Visual Acuity (BCDVA)
Best Corrected Distance Visual Acuity
Measured: 180 Day
Rotational Stability
IOL rotation will be measured through retro-illumination photography between 0-3 hours post-operatively and this will be compared with images from Day 120-180 to determine degree of IOL rotation in accordance with ISO-11979-7:2014 requirements
Measured: 180 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Study was never initiated
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rayner Intraocular Lenses Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Mark Packer, MD, Study chair, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378636
- Sponsor's protocol ID
- 600C-EU-401
- Other IDs
- CFLX-2501
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2015
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
- ClinicalTrials.gov ID
- NCT02378636
- Acronym / sponsor ID
- 600C-EU-401
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rayner Intraocular Lenses LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- 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.
This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 600S | Experimental | Device: 600SModified 600C (axis marks) monofocal aspheric intraocular lens |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged ≥21 years of age.
- Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
- Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
- Calculated IOL power requirement within the range +8.0 to +34.0D
- If present, subject must have corneal astigmatism of <1.50 D in the operative eye.
Key exclusion criteria (11 listed)
- History of ocular trauma or prior ocular surgery in the operative eye.
- Microphthalmia
- Corneal decompensation or endothelial insufficiency
- Pseudo exfoliation
- Pars planitis
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 |
|---|---|---|
| 600SAlso: Modified 600C (axis marks)Monofocal Aspheric Intraocular Lens (IOL) | Device | 600S |
Primary outcome
Best Corrected Distance Visual Acuity (BCDVA)
Time frame: 180 Day
Best Corrected Distance Visual Acuity
Rotational Stability
Time frame: 180 Day
IOL rotation will be measured through retro-illumination photography between 0-3 hours post-operatively and this will be compared with images from Day 120-180 to determine degree of IOL rotation in accordance with ISO-11979-7:2014 requirements
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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.
Mark Packer, MD study chair
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 600S in people with Cataract, run by Rayner Intraocular Lenses Limited at 1 site in United Kingdom.
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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Distance Visual Acuity (BCDVA) (time frame: 180 Day). The study lists 2 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 22 Nov 2023.