Evaluation of visual acuity in patients with previous corneal surgery and AcrySof® IQ VivityTM IOL implantation
| ISRCTN | ISRCTN29845541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29845541 |
- Submission date
- 31/10/2024
- Registration date
- 06/11/2024
- Last edited
- 05/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
This study, conducted from May 2023 to March 2024, aimed to evaluate a new type of lens called the AcrySof® IQ Vivity™ IOL. The focus was on patients who had LASIK surgery for nearsightedness and later needed cataract surgery. The goal was to see how well these patients could see and how accurate their vision correction was after getting the new lens.
Who can participate?
Participants were over 50 years old, needed cataract surgery in both eyes, and met specific eye measurement requirements.
What does the study involve?
Participants underwent comprehensive eye exams before and after surgery. Follow-ups were done at 1 month and 3 months to track vision changes. These exams measured vision clarity at different distances, checked prescriptions, eye pressure, and any visual issues using a questionnaire.
What are the possible benefits and risks of participating?
The benefits include potentially improved vision after cataract surgery with the new lens. The risks are similar to any cataract surgery, such as infection, inflammation, and possible errors in lens power calculation, but these are very rare.
Where is the study run from?
Centro de la Visión (Chile)
When is the study starting and how long is it expected to run for?
September 2022 to March 2024
Who is funding the study?
Alcon Laboratories (Switzerland)
Who is the main contact?
Dr Miguel Srur, msrur@centrodelavision.cl
Contact information
Public, Scientific, Principal Investigator
Camino el Alba 9500
Santiago
7500956
Chile
| Phone | +56 23303000 |
|---|---|
| msrur@centrodelavision.cl |
Study information
| Study design | Prospective interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Evaluation of visual acuity, postoperative refractive error and optical aberrations, in patients with previous corneal surgery and AcrySof® IQ VivityTM IOL implantation |
| Study objectives | Vivity Intraocular Lens improves visual acuity in patients in patients with prior history of myopic LASIK. |
| Ethics approval(s) |
Approved 04/10/2022, Centro de la Vision Ethical Committee (Camino el Alba 9500, Santiago, 7600830, Chile; +56 23303000; hborel@centrodelavision.cl), ref: 102023 |
| Health condition(s) or problem(s) studied | Cataract surgery in patients with prior history of myopic LASIK |
| Intervention | This single-center prospective interventional study assessed eyes with a prior history of corneal refractive laser surgery for myopia that underwent intraocular lens implantation (AcrySof®IQ Vivity TM IOL Alcon) for cataract. Patient assessments included comprehensive ophthalmic examinations before and after Vivity intraocular lens implantation. After the surgery, patients were instructed to use gatifloxacin 0.3%/ prednisolone 1% eye drops four times a day for 1 month. Follow-up was done at 1 and 3 months to assess the visual outcomes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | AcrySof® IQ VivityTM intraocular lens |
| Primary outcome measure | Binocular uncorrected and corrected visual acuity for far distance, measured using LogMAR scale at baseline, 1 and 3 months |
| Secondary outcome measures | 1. Binocular uncorrected and corrected visual acuity of patients for intermediate and near distance (66 and 40 cm respectively) measured using LogMAR scale at baseline, 1 and 3 months 2. Manifest refraction with spherical equivalent (SE) measured using subjective refraction at baseline, 1 and 3 months 3. Intraocular pressure measured using tonometry (mmHg) at baseline, 1 and 3 months 4. Dysphotopsies evaluated using the McAlinden Quality of Vision (QoV) questionnaire at baseline and 3 months |
| Overall study start date | 01/09/2022 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 13 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Patients older than 50 years old 2. Undergoing bilateral phacoemulsification 3. Preoperative corneal higher order aberrations (HOA) less than 0.6 4. Coma less than 0.4 |
| Key exclusion criteria | 1. Glaucoma 2. Macular disease 3. History of retinal detachment 4. Any previous corneal diseases |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- Chile
Study participating centre
Santiago
7600830
Chile
Sponsor information
Hospital/treatment centre
Camino el Alba 9500
Santiago
7600830
Chile
| Phone | +56 23303000 |
|---|---|
| msrur@centrodelavision.cl | |
| Website | https://www.cev.cl |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset generated from this study will be available from Dr Miguel Srur upon reasonable request (msrur@centrodelavision.cl) |
Editorial Notes
01/11/2024: Trial's existence confirmed by Centro de la Vision Ethical Committee.
