Comparing two vision corrective laser eye surgery techniques
| ISRCTN | ISRCTN78153726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78153726 |
- Submission date
- 10/10/2022
- Registration date
- 20/10/2022
- Last edited
- 29/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
This study was performed for spectacle-wearing patients who want refractive surgery (laser surgery) to correct their nearsightedness (myopia). The purpose of the study was to evaluate the differences in two techniques used for corneal epithelial remodeling and their relationship with high-order aberrations of the corneal surface.
Who can participate?
Adults aged between 20 and 35 years old with myopia
What does the study involve?
The study looks at healing after two techniques using the same laser that corrects myopia with or without astigmatism. Participants will receive topoguided Femtolasik (contoura) in one eye and customized by asphericity (custom Q) in the contralateral eye.
What are the possible benefits and risks of participating?
The benefits of participation in the study include receiving corneal refractive surgery with one of the most modern techniques available. The risks are inherent in the procedure, such as infection, for example. But corneal refractive surgery is one of the most performed and safe medical procedures in the world.
Where is the study run from?
Oftalmax – Benfica (Brazil)
When is the study starting and how long is it expected to run for?
December 2018 to January 2022
Who is funding the study?
Investigator initiated and funded (Brazil)
Who is the main contact?
Adriana Falcão Veloso Lyra (Brazil)
adri_falcao@hotmail.com
Contact information
Principal Investigator
Avenida Conselheiro Rosa e Silva,1206
Sala 705 Aflitos
Recife
52050-345
Brazil
| Phone | +55 81991589598 |
|---|---|
| adri_falcao@hotmail.com |
Scientific
Oftalmax
Rua Benfica 411
Madalena
Recife
Peranmbuco
50720-001
Brazil
 ORCID ID |
0000-0001-5184-0905 |
|---|---|
| Phone | +5581 98775-5591 |
| ermanomelo@oftalmax.com.br |
Study information
| Study design | Single-center interventional double-blind randomized prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Epithelial remodeling in Femtolasik Topoguided and customized asphericity in the contralateral eye: a randomized double-blind prospective study |
| Study objectives | The aim of this study is to assess whether there is a difference in corneal epithelial remodeling comparing two corneal refractive surgery techniques. |
| Ethics approval(s) | Approved 04/04/2019, Comitê de Ética em Pesquisa - the Federal University of São Paulo (UNIFESP) (Rua Botucatu, 740. Vila Clementino, São Paulo, SP. CEP: 04023-900, Brazil; +55 (11) 5571-1062/ +55 (11) 5539-7162; cep@unifesp.br), ref: 3.245.443 |
| Health condition(s) or problem(s) studied | Myopia with or without astigmatism |
| Intervention | A randomized double trial: Topoguided femtolasik (contoura) will be performed in one eye and customized by asphericity (Custom-Q) in the contralateral eye. In January 2019, the design of the research study began. After the approval of the ethics committee, the study started the screening of patients who would receive refractive surgery. On the day of the surgery, patients were randomized using a randomization program to choose the surgical technique that would be performed in the patient's right eye and the other technique in the contralateral eye. All patients performed a complete ophthalmological examination, including complementary exams. Both groups received the same treatment drops. Both techniques provide excellent results. The difference would be the form of laser ablation. Patients underwent ophthalmological examinations and complementary imaging exams on day 1, week 1, and months 1 and 3, and 1 year after the surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Visual acuity (logMAR chart) measured using a digital projector with and without correction at 1 day, 1 month, and 3 months post-operatively |
| Secondary outcome measures | 1. Ephthelial remodeling in microns measured using an OCT Avanti that evaluates the epithelial thickness map generated by an automatic algorithm and divided into a total of 17 sectors (central, paracentral and mid-periphery) preoperatively and at 3 months 2. Cornea total root mean square (RMS) (total high order aberrations on Cornea surface) measured using corneal tomography with the Galilei G6 using the Zernike map preoperatively and at 3 months postoperatively |
| Overall study start date | 31/12/2018 |
| Completion date | 01/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Myopic patients with or without astigmatism 2. Aged between 20-35 years old 3. Spherical degree up to 8 and cylinder up to 3 |
| Key exclusion criteria | 1. Keratoconus or predisposing topographic changes 2. Pachymetry below 500 3. PTA above 40 4. Previous eye surgery 5. Glaucoma 6. Dry eye 7. Cataract 8. Systemic diseases |
| Date of first enrolment | 30/04/2019 |
| Date of final enrolment | 31/01/2021 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Madalena
Recife
50720-001
Brazil
Sponsor information
Hospital/treatment centre
Rua Benfica
411. Madalena
Recife
50720-001
Brazil
| Phone | +55 8130362727 |
|---|---|
| aaffvvll@icloud.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2023 | 29/12/2023 | Yes | No |
Editorial Notes
29/12/2023: Publication reference added.
17/10/2022: Trial's existence confirmed by the Research Ethics Committee of The Federal University of São Paulo.
