AphakiaNCT03729024
Exploratory 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
A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 1 site in Mexico.
Trial summary
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- Light Adjustable lens (LAL) and Light Delivery Device (LDD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteMexico
- Study dates
- 26 Jan 2018to 4 Feb 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 to 80 years
- 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 unilateral or bilateral implantation of the RxLAL.
- Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
- Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
- Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
- Willing and able to comply with the requirements for study specific procedures and visits.
Who cannot join
- Study eye with zonular laxity or dehiscence.
- Study eye with pseudoexfoliation.
- Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Study eye with diabetes with any evidence of retinopathy.
- Study eye with evidence of glaucomatous optic neuropathy.
- Study eye with history of uveitis.
Show all 11Show fewer
- Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless the pterygium did not extend more than 2mm onto the cornea from the limbus.
- Subjects taking systemic medication that may increase sensitivity to UV light.
- Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
- Study eye with history of ocular herpes simplex virus.
- Study eye with history of a congenital color vision defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Exploratory 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
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.
- Being tested
- Light Adjustable lens (LAL) and Light Delivery Device (LDD)
- Keywords
- Light Adjustable Lens, Intraocular lens, LAL
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Adjustable lens (LAL) and Light Delivery Device (LDD)Device
Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
| Study group | Role | What they receive |
|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Experimental | Not described Receives: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Eyes With UCDVA of 20/20 or Better
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start26 Jan 2018
- Primary completion15 Apr 2019
- Study completion4 Feb 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 AphakiaStudies 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
- Model description
- All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- RxSight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729024
- Sponsor's protocol ID
- CSP-028
- Status last verified
- Aug 2021
- First submitted
- 31 Oct 2018
- Last updated
- 6 Aug 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Exploratory 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
- NCT03729024
- Acronym / sponsor ID
- CSP-028
- Keywords
- Light Adjustable Lens, Intraocular lens, LAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- RxSight, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.
| Arm | Type | Receives |
|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Experimental | Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) |
Who may qualify
- Ages
- 40 to 80 years
- 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 unilateral or bilateral implantation of the RxLAL.
- Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
- Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
- Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
- Willing and able to comply with the requirements for study specific procedures and visits.
Key exclusion criteria (11 listed)
- Study eye with zonular laxity or dehiscence.
- Study eye with pseudoexfoliation.
- Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- Study eye with diabetes with any evidence of retinopathy.
- Study eye with evidence of glaucomatous optic neuropathy.
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 |
|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD)Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments | Device | Light adjustable lens (LAL) and Light Delivery Device (LDD) |
Primary outcome
Percent of Eyes With UCDVA of 20/20 or Better
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 1 site in Mexico.
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 6 Aug 2021. 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 Mexico. 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 19 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?
Percent of Eyes With UCDVA of 20/20 or Better (time frame: 6 months). 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 6 Aug 2021.