Comparing standard myopic LASIK to contralateral eye LASIK customised with a novel software already EU approved
| ISRCTN | ISRCTN73528436 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73528436 |
| Secondary identifying numbers | LV002 |
- Submission date
- 03/05/2023
- Registration date
- 14/09/2023
- Last edited
- 29/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
LASIK is a type of eye surgery that can fix nearsightedness. It has been used a lot in the past and is considered safe and effective. This study is trying to see if a new way of doing the surgery, called automated ray-tracing optimization, is as safe and effective as another way called Custom Q excimer profile ablation.
Who can participate?
Adults undergoing femtosecond laser-assisted LASIK in the LaserVision Ambulatory Eye Surgery Unit.
What does the study involve?
In this study, 25 people will have LASIK surgery done with the help of a femtosecond laser. The surgery will be done on both eyes of each person, but one eye will be treated with a new technique called raytracing customization, and the other eye will be treated with a technique called asphericity-adjusted (custom) excimer profile ablation. The patients will be carefully watched to see how well the different treatments work and to make sure they are safe.
What are the possible benefits and risks of participating?
Participants will correct their refractive error. The known risks for refractive surgery apply, such as infection, dry eyes, glare, halos or need for additional correction at a later date.
Where is this study run from?
It is run by the LaserVision Ambulatory Eye Surgery Unit in Greece
When is the study starting and how long is it expected to run for?
April 2023 to December 2023
Who is funding the study?
Alcon LLC (USA)
Who is the main contact?
Anastasios John Kanellopoulos
ajkmd@mac.com
Contact information
Principal Investigator
Tsocha 17
Athens
11521
Greece
 ORCID ID |
0000-0003-3595-3517 |
|---|---|
| Phone | +30 (210) 74 72 777 |
| info@laservision.gr |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Contralateral Eye myopic LASIK customization comparison Custom Q vs Ray Tracing (Wavelight Plus) |
| Study acronym | CustomVsRay |
| Study objectives | Visual performance can be superior in Ray-tracing compared to custom Q |
| Ethics approval(s) |
Approved 15/03/2023, LaserVision Ethics Committee (Tsocha 17, Athina, 115 21, Greece; +30 2107472777; info@laservision.gr), ref: 49/4/213 |
| Health condition(s) or problem(s) studied | Treatment of myopic refractive error with LASIK |
| Intervention | For each patient undergoing LASIK treatment correction, one eye is randomly assigned to be treated with raytracing customization and the other with asphericity adjusted (custom Q) excimer profile ablation, both CE approved options on the same device (EX500 excimer laser). This study will evaluate the visual function outcomes. Randomisation of the treatment allocation will be made by flipping a coin. Both eyes will be evaluated pre-operatively for both modalities and treatment allocation will be made at the time of surgery. All measurements, procedures and post care are estimated to take 3-6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pre- and Post- operation mean refractive error is measured with an autorefractor 2. Topographic astigmatism is measured using keratometry at Pre- and Post- operation |
| Secondary outcome measures | Visual Acuity is measured using the Snellen chart at Pre- and Post- operation |
| Overall study start date | 01/04/2023 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | Adults undergoing refractive error laser correction with no other corneal/ocular pathology (ie. Keratoconus, Pterygium) other than refractive error |
| Key exclusion criteria | Corneal/Ocular pathology other than refractive error |
| Date of first enrolment | 15/04/2023 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- Greece
Study participating centre
Athens
11521
Greece
Sponsor information
Hospital/treatment centre
Tsocha 17
Athens
11521
Greece
| Phone | +30 (210) 74 72 777 |
|---|---|
| infoajkmd@laservision.gr | |
| Website | http://www.kanellopouloseyecenter.net/US/indexus.htm |
"ROR" |
https://ror.org/02xm4cz36 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request ajkmd@mac.com, Anastasios John Kanellopoulos |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 28/08/2023 | 29/08/2023 | No | No |
Additional files
Editorial Notes
29/08/2023: Trial's existence confirmed by LaserVision Ethics Committee.
