Visual outcomes using the light adjustable lens in patients with previous LASIK and/or PRK (laser eye surgery)
| ISRCTN | ISRCTN57719133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57719133 |
| Secondary identifying numbers | 7459325 |
- Submission date
- 21/02/2023
- Registration date
- 21/02/2023
- Last edited
- 20/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
The Light Adjustable Lens (LAL) from RxSight, Inc. (Aliso Viejo, CA) is an intraocular lens (IOL) used in cataract surgery that enables vision customization after implantation and ocular healing has occurred.
A second-generation IOL from RxSight (LAL 2.0) incorporates an enhanced UV absorber (ActivShield) that may increase the stability of the IOL and refractive outcomes.
Patients with a history of previous refractive surgery pose problems with postoperative refractive error following cataract surgery. This population of patients is particularly well-suited for LAL technology.
Previous studies have reported good outcomes of the LAL in post refractive patients, but a large-sample clinical study has yet to be published on post LASIK or PRK patients electing for the second-generation ActivShield LAL (LAL 2.0) in the peer reviewed literature. The aim of this study is to report on the safety and visual acuity (VA) outcomes using the second generation, ActivShield LAL (LAL 2.0) in patients with previous history of LASIK or PRK. To our knowledge, this retrospective study will be the first report of visual outcomes using the ActiShieldTM (LAL 2.0) in post LASIK or PRK patients in the peer-reviewed literature.
Who can participate?
Patients with previous history of LASIK and/or PRK undergoing cataract surgery with use of the ActivShield LAL (LAL 2.0) and adequate pupil dilation of 6.5 mm or more.
What does the study involve?
Having cataract surgery and using the ActivShield LAL as the IOL implant at the time of the cataract surgery. It will involve up to 5 follow-up light treatments to adjust the power of the LAL after surgery to further improve the patient's vision.
What are the possible benefits and risks of participating?
The benefits would include improved vision from correction of the cataract and improved vision from correction of refractive error (glasses) through adjustment of the power of the LAL after surgery. All surgery and testing is “standard of care” with no “study specific” surgery or tests performed. Risks are related to those of cataract surgery including vision loss and the need for additional surgery.
Where is the study run from?
It is run from the surgery centers where cataract surgeries are performed and Praxis Vision where the post-op light treatments are performed (USA)
When is the study starting and how long is it expected to run for?
This retrospective chart review will look at patients from approximately July, 2021, through December, 2022.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
David V. Folden, MD, dfolden@nseyespecialists.com
Contact information
Principal Investigator
10452 Vermillion Cir NE
Blaine
55449
United States of America
 ORCID ID |
0000-0002-9912-7719 |
|---|---|
| Phone | +1 6129643234 |
| dfolden@nseyespecialists.com |
Study information
| Study design | Observational retrospective chart review |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Medical and other records |
| Study type | Other |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Visual outcomes using an enhanced UV protected light adjustable lens in patients with previous LASIK and/or PRK |
| Study acronym | VOwLAL for PO-LASIK & PRK |
| Study hypothesis | The second-generation, ActivShield LAL (LAL 2.0), used in patients undergoing cataract surgery and with previous history of LASIK or PRK should provide excellent refractive outcomes. |
| Ethics approval(s) | Approved 15/02/2023, SALUS IRB (2111 W. Braker Lane, Ste 300, Austin, TX 78758, USA; +1 888-834-6632; clientservices@salusirb.com), ref: 2023.02.15 Exempt Determination |
| Condition | Use of the Light Adjustable Lens in Post-LASIK and PRK patients |
| Intervention | This retrospective observational case series assessed the VA and safety outcomes of a consecutive series of post LASIK or PRK patients after cataract extraction and IOL implantation with the ActivShieldTM LAL 2.0 in a private practice setting between July 2021 and December 2022. The primary outcome measures for this study were monocular uncorrected distance visual acuity (UDVA), monocular mean spherical equivalent (SE), and monocular mean residual cylinder for emmetropic-goal eyes at the 3+ month post surgical follow-up. Safety outcomes reported include serious adverse events (AEs) occurring at the time of surgery extending out to the final postoperative examination. All final postoperative exams included slit lamp biomicroscopy, intraocular pressure, MRx with corrected distance visual acuity (CDVA), and uncorrected distance visual acuity (UDVA). Distance VA testing was achieved using a computer calibrated Snellen chart under photopic conditions. A standard phoropter was used to determine the subjective MRx rounded to steps of 0.25 D. All testing was “standard of care” and there were no “study specific” tests performed. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured using patient records: 1. Monocular uncorrected distance visual acuity (UDVA) 2. Monocular mean spherical equivalent (SE) 3. Monocular mean residual cylinder for emmetropic-goal eyes at the 3+ month post surgical follow-up. 4. Safety outcomes reported include serious adverse events (AEs) occurring at the time of surgery extending out to the final postoperative examination. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2021 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | Approximately 40 patients and 50 eyes. |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Patients who receive the ActivShield LAL with their cataract surgery 2. Have previous history of LASIK and/or PRK 3. Have pupil dilation of 6.5 mm or greater 4. Age between 40-90 years |
| Participant exclusion criteria | Patients with retinal or macular disease, clinically significant corneal abnormalities, corneal scarring, or ectasia were excluded from the study. |
| Recruitment start date | 01/07/2021 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Blaine
55434
United States of America
Edina
55435
United States of America
Edina
55435
United States of America
Sponsor information
Hospital/treatment centre
3777 Coon Rapids Blvd NW, Suite 100
Coon Rapids
55433
United States of America
| Phone | +1 7630-421-7420 |
|---|---|
| dfolden@nseyespecialists.com | |
| Website | https://nseyespecialists.com/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Existing medical records are kept at the Twin Cities Eye Consultants’ clinic locations and LDD treatment records at Praxis Vision. Patients will be de-identified in the analysis and be assigned a Subject ID number. Electronic charts are stored in a computer which is password protected. The database used for analysis will also be password protected. The Principal Investigator and the LDD Specialist will perform the analysis. The data used for analysis will be stored according to Clinic guidelines which is generally seven years. The outcomes analysis database would be stored for 7 years, and deleted electronically. Consents from participants will not be obtained because of the retrospective design of the study and all PHI will be de-identified. It has already received "Exempt" status approval from Salus IRB. Data will be available through attempted publication. Any raw data generated during the current study are not expected to be made available unless requested by the publication source after the manuscript is submitted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/11/2023 | 20/11/2023 | Yes | No |
Editorial Notes
20/11/2023: Publication reference added.
21/02/2023: Trial's existence confirmed by Salus IRB.
