CataractNCT00960700
A Multi Focal Visual Outcome Study Using Different Near Additions
An observational study of Cataract and Aphakia, run by Rayner Intraocular Lenses Limited at 2 sites in 2 countries.
Trial summary
A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Visual Acuity, Contrast sensitivity and Reading Speed
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2009to Aug 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aphakic adults with potential for > 20/40 visual outcome to participate in a binocular study. Subjects to be implanted bilaterally with study device.
Who may be able to join
- Age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact
- Patients requiring primary IOL implantation
- Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment
- Patients with normal anterior segments - apart from cataracts
- Subjects with clear intraocular media other than cataract
Who cannot join
- Pre-existing pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following:
- Microphthalmia
- Corneal decompensation or Endothelial Insufficiency
- Pseudo exfoliation
- High myopia
- Pars planitis
Show all 16Show fewer
- Patient with greater than 1 dioptre of pre-operative corneal astigmatism
- Subjects who are expected to require retinal laser treatment
- Previous intraocular and/or corneal surgery
- History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
- Operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location
- Subjects using a systemic medication that is known to cause ocular side effects
- Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
- Subjects who have only one eye with potentially good vision
- Patients who are not willing to cooperate in the 6-months follow-up period
- Children under the age of 18 years
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Ruprecht- Karl Universitat Heidelberg
Abteilung Augenheilkunde, Heidelberg, 69120
Lithuania1 site
Eye Clinic and national Centre of Ophthalmology
Kaunas, LT-44307
About this study
Official title: Clinical Investigational Plan of the Rayner M-flex Multifocal Intraocular Lens (IOL) With Different Near Additions
A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.
- Being tested
- Visual Acuity, Contrast sensitivity, Reading Speed, Eye Health
- Keywords
- MFlex, Multifocal, 630F
- Medical subject headings
- Cataract, Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityDevice
Assessment of visual acuity
Contrast sensitivityDevice
Assessment of contrast sensitivity
Reading SpeedDevice
Assessment of reading speed
Eye HealthProcedure or surgery
Examination of eye health through use of a slitlamp/ photography. Assessment of Intraocular Pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity at distance and near
Measured: 1 year
Secondary outcomes (3)
Range of clear vision
Measured: 1 year
Reading speed
Measured: 1 year
Cntrast sensitivity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rayner Intraocular Lenses Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerd U Auffarth, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960700
- Sponsor's protocol ID
- Rayner-630F
- Status last verified
- Feb 2013
- First submitted
- 17 Aug 2009
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigational Plan of the Rayner M-flex Multifocal Intraocular Lens (IOL) With Different Near Additions
- ClinicalTrials.gov ID
- NCT00960700
- Acronym / sponsor ID
- Rayner-630F
- Keywords
- MFlex, Multifocal, 630F
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rayner Intraocular Lenses LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 18 Aug 2009 (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.
A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aphakic adults with potential for > 20/40 visual outcome to participate in a binocular study. Subjects to be implanted bilaterally with study device.
Key inclusion criteria (5 listed)
- Age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact
- Patients requiring primary IOL implantation
- Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment
- Patients with normal anterior segments - apart from cataracts
- Subjects with clear intraocular media other than cataract
Key exclusion criteria (16 listed)
- Pre-existing pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following:
- Patient with greater than 1 dioptre of pre-operative corneal astigmatism
- Subjects who are expected to require retinal laser treatment
- Previous intraocular and/or corneal surgery
- History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
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 |
|---|---|---|
| Visual AcuityAssessment of visual acuity | Device | – |
| Contrast sensitivityAssessment of contrast sensitivity | Device | – |
| Reading SpeedAssessment of reading speed | Device | – |
| Eye HealthExamination of eye health through use of a slitlamp/ photography. Assessment of Intraocular Pressure. | Procedure or surgery | – |
Primary outcome
Visual acuity at distance and near
Time frame: 1 year
3 secondary outcomes
Range of clear vision
Time frame: 1 year
Reading speed
Time frame: 1 year
Cntrast sensitivity
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Publication from the resultsLink provided by the sponsor.
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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.
Gerd U Auffarth, Prof. principal investigator
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Aphakia, run by Rayner Intraocular Lenses Limited at 2 sites in 2 countries.
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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Lithuania. 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 stopped early. Results are not available in the source record.
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?
Visual acuity at distance and near (time frame: 1 year). 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 8 Feb 2013.