Visual outcomes using a comanaged and open access method for the Light Adjustable Lens® in cataract surgery
| ISRCTN | ISRCTN55809023 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55809023 |
| Secondary identifying numbers | 7459325 |
- Submission date
- 20/04/2022
- Registration date
- 28/04/2022
- Last edited
- 04/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
To assess the safety and effectiveness of cataract surgery using the Light Adjustable Lens (LAL) using two doctors, co-managing for each patient. The surgeon will do the surgery and a medical provider will do light treatments to the LAL to further improve vision after surgery. Surgery and light treatments will be done in different locations. Light treatments will be done in a facility that is open access for patients of other surgeons.
Who can participate?
Patients that have cataracts, wanting the LAL and do not have any diseases of the macula or cornea.
What does the study involve?
Having cataract surgery and using the 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 are “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 center where cataract surgery is performed and the TCEC LASIK Center where the post-op light treatments are performed (USA)
When is the study starting and how long is it expected to run for?
July 2021 to January 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
David V. Folden, MD
foldav@gmail.com
Contact information
Principal Investigator
10452 Vermillion Cir NE
Blaine
55449
United States of America
 ORCID ID |
0000-0002-9912-7719 |
|---|---|
| Phone | +1 612-396-9574 |
| dfolden@nseyespecialists.com |
Study information
| Study design | Observational retrospective case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Novel care delivery model for the RxSight Light Adjustable Lens®: a co-managed, open-access methodology |
| Study acronym | NCDM LAL CoMOA |
| Study objectives | Using a comanaged arrangement at an open access facility, use of the Light Adjustable Lens in cataract surgery is safe and efficacious. |
| Ethics approval(s) | Ethics approval is not required given its retrospective chart review design, confirmed by Salus IRB. |
| Health condition(s) or problem(s) studied | Use of the Light Adjustable Lens in patients with cataracts and receiving cataract surgery |
| Intervention | Observational retrospective case series chart review of a consecutive series of patients in a private practice setting between July 2021 and January 2022. The visual acuities, manifest refractions, and adverse events were evaluated in the charts of patients that underwent cataract surgery using the light adjustable lens. Data was extracted from the patient's final postoperative visit sometime between 3 and 9 months postoperatively. |
| Intervention type | Other |
| Primary outcome measure | Collected by retrospective chart review between 3 and 9 months postoperatively: 1. Uncorrected monocular and binocular distance 2. Near visual acuities 3. Safety |
| Secondary outcome measures | Collected by retrospective chart review between 3 and 9 months postoperatively: 1. Manifest refraction |
| Overall study start date | 01/07/2021 |
| Completion date | 31/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 32 |
| Total final enrolment | 32 |
| Key inclusion criteria | Patients who received cataract surgery and management of their Light Adjustable Lens using a comanaged approach at an open access facility. |
| Key exclusion criteria | 1. Retinal or macular disease 2. Clinically significant corneal abnormalities 3. Corneal scarring 4. Ectasia |
| Date of first enrolment | 01/07/2021 |
| Date of final enrolment | 31/01/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Blaine
55434
United States of America
Edina
55435
United States of America
Sponsor information
Industry
3777 Coon Rapids Blvd NW Suite 100
Coon Rapids
55443
United States of America
| Phone | +1 763-421-7420 |
|---|---|
| ahalabi@nseyespecialists.com | |
| Website | http://www.nseyespecialists.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets will be de-identified with no PHI patient specific data being used in the analysis. 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? |
|---|---|---|---|---|---|
| Protocol file | 27/04/2022 | No | No | ||
| Results article | 04/08/2022 | 04/01/2023 | Yes | No |
Additional files
Editorial Notes
04/01/2023: Publication reference added.
27/04/2022: Trial's existence confirmed by Salus IRB.
