AphakiaNCT04005586
A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
A study testing Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- Light Delivery Device (LDD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2019to 1 Mar 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
- A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
- A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
- Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
- Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
- Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
- Willing and able to comply with the requirements for study specific procedures and visits
Who cannot join
- Pre-existing macular disease in the study eye.
- History of uveitis in the study eye.
- Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and eyes with previous pterygium excision are permitted as long as 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.
- History of ocular herpes simplex virus in the study eye.
- Subject who has participated within another ophthalmic clinical trial within the last 3 months.
- Sutures used at the time of surgery to close the incision wound in the study eye
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108
About this study
Official title: A Prospective Controlled Multi-Center Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.
- Being tested
- Light Delivery Device (LDD)
- Keywords
- Light Delivery Device, LDD, Intraocular lens, Light Adjustable 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 Delivery Device (LDD)Device
Study eye will undergo Light delivery Device treatments
| Study group | Role | What they receive |
|---|---|---|
| Light Delivery Device (LDD) | Experimental | Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Receives: Device: Light Delivery Device (LDD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Measured: Post Op Month 3
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Measured: Post Op Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 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
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT04005586
- Sponsor's protocol ID
- CSP-034
- Status last verified
- May 2021
- First submitted
- 26 Jun 2019
- Last updated
- 11 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 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Multi-Center Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
- ClinicalTrials.gov ID
- NCT04005586
- Acronym / sponsor ID
- CSP-034
- Keywords
- Light Delivery Device, LDD, Intraocular lens, Light Adjustable Lens, LAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- RxSight, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 11 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.
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
| Arm | Type | Receives |
|---|---|---|
| Light Delivery Device (LDD) | Experimental | Device: Light Delivery Device (LDD)Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
- A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
- Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
- Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
- Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
Key exclusion criteria (8 listed)
- Pre-existing macular disease in the study eye.
- History of uveitis in the study eye.
- Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and eyes with previous pterygium excision are permitted as long as 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.
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 Delivery Device (LDD)Study eye will undergo Light delivery Device treatments | Device | Light Delivery Device (LDD) |
Primary outcome
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time frame: Post Op Month 3
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time frame: Post Op Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Aphakia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
Aphakia, Presbyopia
Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Aphakia
Not yet recruiting
Clinical Evaluation of the Adaptilens Accommodating IOL
Aphakia Cataract
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 2 sites in United States.
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 8 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 11 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 2 sites in United States. 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 11 Jun 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?
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups (time frame: Post Op Month 3). 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 11 Jun 2021.