AphakiaNCT03660865

Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive… Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Aphakia, Cataract
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: 105 participants
Where: 6 sitesUnited States
Study dates: 28 Aug 2018to 1 Apr 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 the bilateral implantation of an intraocular lens (IOL).
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.
Willing and able to comply with the requirements for study specific procedures and visits.
Able to complete a written questionnaire in English.

Who cannot join

Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
Pre-existing macular disease in either eye.
Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
History of uveitis in either eye.
Evidence of ectasia in either eye.
Previous intraocular surgery in either eye. 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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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 either eye.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Cleveland Eye Clinic
Brecksville, Ohio, 44141
Slade & Baker Vision
Houston, Texas, 77027
Discover Vision Centers
Leawood, Kansas, 66211
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Focal Point Vision
San Antonio, Texas, 78229
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

Conditions: Aphakia, Cataract
Being tested: Light Adjustable lens (LAL) and Light Delivery Device (LDD), Control IOL
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 eye will receive Light adjustable lens with Light delivery Device treatments
Control IOLDevice
Fellow eye will receive control IOL

Study groups in NCT03660865
Study group	Role	What they receive
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Experimental	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Receives: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Control IOL	Active comparator	A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Receives: Device: Control IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Measured: Postop Month 6
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Measured: Postop Month 6
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Measured: Postop Month 6

Secondary outcomes (2)

Uncorrected Distance Visual Acuity (UCDVA)
Measured: Postop Month 6
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Measured: Postop Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20181 Apr 2020

First posted7 Sep 2018
Study start28 Aug 2018
Primary completion1 Apr 2020
Study completion1 Apr 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: Randomised
Intervention model: Single group
Model description: All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03660865
Sponsor's protocol ID: CSP-027
Status last verified: Nov 2021
First submitted: 29 Aug 2018
Last updated: 23 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
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

All Aphakia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
ClinicalTrials.gov ID: NCT03660865
Acronym / sponsor ID: CSP-027
Conditions: Aphakia, Cataract
Keywords: Light Adjustable Lens, Intraocular lens, LAL
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: RxSight, Inc.Industry (pharma, biotech, devices)
Study start: 28 Aug 2018 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 7 Sep 2018 (actual)
Results: Posted 22 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.

Arm	Type	Receives
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Experimental	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Control IOL	Active comparator	Device: Control IOLA pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL).
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.
Willing and able to comply with the requirements for study specific procedures and visits.

Key exclusion criteria (9 listed)

Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
Pre-existing macular disease in either eye.
Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
History of uveitis in either eye.
Evidence of ectasia in either eye.

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 eye will receive Light adjustable lens with Light delivery Device treatments	Device	Light adjustable lens (LAL) and Light Delivery Device (LDD)
Control IOLFellow eye will receive control IOL	Device	Control IOL

Primary outcome

Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Time frame: Postop Month 6

2 secondary outcomes

Uncorrected Distance Visual Acuity (UCDVA)
Time frame: Postop Month 6
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Time frame: Postop Month 6

Results and safety

Results posted to the registry on 22 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	105	105
Control IOL	105	105

Primary outcome: Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control

Time frame: Postop Month 6. Mean (Standard Deviation). Unit: Diopter

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 105	Control IOL n = 105
Value	-0.319 (0.319)	-0.452 (0.456)

Primary outcome: Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control

Time frame: Postop Month 6. Mean (Standard Deviation). Unit: Diopter

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 105	Control IOL n = 105
Value	0.269 (0.269)	0.379 (0.338)

Primary outcome: One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%

Time frame: Postop Month 6. Number (95% Confidence Interval). Unit: percent of eyes w. BCDVA 20/40 or better

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 105
Value	100 (100 to 100)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	1 of 105 (1%)	48 of 105 (45.7%)	0 of 105
Control IOL	0 of 105 (0%)	38 of 105 (36.2%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Aphakia

Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
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Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
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Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
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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.

6 sites 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 6 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 9 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 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 22 Nov 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?

Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control (time frame: Postop Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03660865.

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 23 Dec 2021.