CataractNCT03771352
Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism
A study testing RxSight RxLAL in people with Cataract, run by RxSight, Inc. at 3 sites in 2 countries.
Trial summary
For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- RxSight RxLAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Jun 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL.
- Greater than the age of 40 on the day the cataract surgery is performed.
- Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
- Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
- Willing and able to comply with the requirements for study specific procedures and visits.
Who cannot join
- Zonular laxity or dehiscence.
- Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
- History of uveitis
- Keratoconus or suspected of having keratoconus.
- Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
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- Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
- Subjects taking systemic medications that may increase sensitivity to UV light.
- Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
- History of ocular herpes simplex virus
- History of congenital color vision defect
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom1 site
Ayrshire Eye Clinic and Laser Center
Ayr, Scotland
About this study
Official title: A Prospective Multi-Center Clinical Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RxLAL) With the Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.
- Conditions
- Cataract
- Being tested
- RxSight RxLAL
- Keywords
- cataract surgery, eye disease, lenticular opacification
- Medical subject headings
- Cataract, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RxSight RxLALDevice
Also called Light Adjustable Lens, Light Delivery Device
The patients will be assessed for 6 months
| Study group | Role | What they receive |
|---|---|---|
| RxSight RxLAL IOL | Other | Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) Receives: Device: RxSight RxLAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
Measured: at 6 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start19 Jun 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- RxSight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burkhard Dick, MD, Principal investigator, University Eye Clinic- Bochum, GermanyFritz Hengerer, MD, Principal investigator, University Eye Clinic- Heidelberg, GermanySathish Srinivasan, MD, Principal investigator, Ayrshire Eye Clinic and Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771352
- Sponsor's protocol ID
- CSP-025-03
- Status last verified
- May 2021
- First submitted
- 30 Nov 2018
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Clinical Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RxLAL) With the Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
- ClinicalTrials.gov ID
- NCT03771352
- Acronym / sponsor ID
- CSP-025-03
- Conditions
- Cataract
- Keywords
- cataract surgery, eye disease, lenticular opacification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- RxSight, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RxSight RxLAL IOL | Other | Device: RxSight RxLALEligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL.
- Greater than the age of 40 on the day the cataract surgery is performed.
- Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
- Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
- Willing and able to comply with the requirements for study specific procedures and visits.
Key exclusion criteria (11 listed)
- Zonular laxity or dehiscence.
- Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
- History of uveitis
- Keratoconus or suspected of having keratoconus.
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 |
|---|---|---|
| RxSight RxLALAlso: Light Adjustable Lens, Light Delivery DeviceThe patients will be assessed for 6 months | Device | RxSight RxLAL IOL |
Primary outcome
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Time frame: at 6 months postop
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Burkhard Dick, MD principal investigator
University Eye Clinic- Bochum, Germany
Fritz Hengerer, MD principal investigator
University Eye Clinic- Heidelberg, Germany
Sathish Srinivasan, MD principal investigator
Ayrshire Eye Clinic and Laser Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RxSight RxLAL in people with Cataract, run by RxSight, Inc. at 3 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 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: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, 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?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better (time frame: at 6 months postop). 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 9 Jun 2021.