Use of artificial tears in patients treated with eye (intravitreal) injections
| ISRCTN | ISRCTN77853517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77853517 |
| Secondary identifying numbers | ITT#63239827 |
- Submission date
- 30/01/2021
- Registration date
- 17/02/2021
- Last edited
- 08/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Current plain English summary as of 06/04/2021:
Background and study aims
An intravitreal injection is a shot of medicine into the eye. The inside of the eye is filled with a jelly-like fluid (vitreous). During this procedure, your health care provider injects medicine into the vitreous, near the retina at the back of the eye. The medicine can treat certain eye problems and help protect your vision. This method is most often used to get a higher level of medicine to the retina.
This treatment is a likely factor in the development of dry eye syndrome.
The aim of this study is to evaluate the benefit of use of artificial tears in patients submitted to this treatment.
Who can participate?
Patients aged 50+ years with anti-vascular endothelial growth treatment
What does the study involve?
Participants will be randomly allocated to receive Systane Ultra Plus Hydration or Viscofresh 10mg/ml eye drops. At baseline, at 7, 30, 37 and 60 days after baseline, the eyes will undergo an examination.
What are the possible benefits and risks of participating?
The potential benefits of the study and for the individual study participant in the study group are that the use of artificial tears during anti-vascular endothelial growth treatment may reduce ocular discomfort.
Risks: None
Where is the study run from?
Oftalvist (Spain)
When is the study starting and how long is it expected to run for?
December 2020 to August 2022
Who is funding the study?
Oftalmología Vistahermosa SL (Spain)
Who is the main contact?
Dr Francisco Pastor-Pascual, franciscopastorpascual@gmail.com
Contact information
Scientific
Oftalvist. Av. de la Ilustración, 1
Burjassot
46100
Spain
| Phone | +34 963 00 30 18 |
|---|---|
| fpastor@oftalvist.es |
Study information
| Study design | Two arm randomized prospective comparative examiner masked clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Ocular discomfort following use of artificial tears in patients under treatment of intravitreal injections of anti-vascular endothelial growth factor agents |
| Study acronym | Antiveg-tears |
| Study hypothesis | The use of lubricant after intravitreous injections reduces the symptoms of ocular surface discomfort |
| Ethics approval(s) | Approved 23/03/2021, Hospital Clinico San Carlos (Puerta G - 4ª Norte, Madrid 28040 Madrid, Spain; +34 91 330 34 13; ceic.hcsc@salud.madrid.org), ref: 21/164-EC_P |
| Condition | Age-related macular degeneration |
| Intervention | Current interventions as of 06/04/2021: All patients will be randomly assigned to use one of two treatments (Dose A: Viscofresh 10mg/ml or Dose B: Systane Ultra Plus Hydration). Before randomization, all patients will be evaluated at the first recruitment visit (without Dose). After this first visit, if they are included, they will be assigned with the treatment of Dose A or Dose B. At the end of the visit they will receive the Ranibizumab injection (following their usual treatment) and will not receive any dose. They will be subsequently evaluated a week and a month. At the end of the month's visit, they will receive a Ranibizumab injection and the Dose prescribed (A or B depending on randomization). The next visit will be at one week and one month to evaluate the results. _____ Previous interventions: All patients will be randomly assigned to use one of two treatments (Dose A: 0.9% saline or Dose B: Systane Ultra Plus Hydration). Before randomization all patients will be evaluated at the first recruitment visit (without Dose). After this first visit, if they are included, they will be assigned with the treatment of Dose A or Dose B. At the end of the visit they will receive the Ranibizumab injection (following their usual treatment) and will not receive any dose. They will be subsequently evaluated a week and a month. At the end of the month's visit, they will receive a Ranibizumab injection and the Dose prescribed (A or B depending on randomization). The next visit will be at one week and one month to evaluate the results. |
| Intervention type | Other |
| Primary outcome measure | Ocular Surface Discomfort Index questionnaire measured at baseline, 7, 30, 37 and 60 days. |
| Secondary outcome measures | Measured at baseline, 7, 30, 37 and 60 days: 1. Meniscus tear height measured using Keratograph device 2. Conjunctival hyperemia measured using Keratograph device 3. Non-invasive keratographic tear film break-up time (BUT) measured using Keratograph device 4. Dry eye symptoms measured using the DEQ-5 questionnaire 5. Corneal staining measured using Keratograph device 6. Fluorescein BUT measured using Keratograph device 7. Meibomiography measured using Keratograph devie |
| Overall study start date | 01/12/2020 |
| Overall study end date | 03/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 34 |
| Participant inclusion criteria | Current inclusion criteria as of 06/04/2021: 1. Patients with anti-vascular endothelial growth treatment with Lucentis 10mg/ml (ranibizumab, Novartis) for age-related macular degeneration 2. Patients must have already received a minimum of three injections of this treatment 3. Age between 51 and 90 years _____ Previous inclusion criteria: 1. Patients with anti-vascular endothelial growth treatment with Lucentis 10mg/ml (ranibizumab, Novartis) for age-related macular degeneration 2. Patients must have already received a minimum of three injections of this treatment 3. Age between 50 and 90 years |
| Participant exclusion criteria | 1. Glaucoma 2. Dry eye 3. Previous refractive surgery or recent cataract surgery (less than 6 months) |
| Recruitment start date | 01/04/2021 |
| Recruitment end date | 01/09/2021 |
Locations
Countries of recruitment
- Spain
Study participating centre
Burjassot
46100
Spain
Sponsor information
Hospital/treatment centre
Av. de la Ilustración, 1.
Burjassot
46100
Spain
| Phone | +34 628379731 |
|---|---|
| maria.cobo@oftalvist.es | |
| Website | https://www.oftalvist.es |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/11/2022 | 08/12/2022 | Yes | No |
Editorial Notes
08/12/2022: Publication reference and total final enrolment added.
08/11/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2021 to 03/08/2022.
2. The intention to publish date was changed from 01/09/2021 to 01/12/2022.
3. The plain English summary was updated to reflect these changes.
06/04/2021: The following changes were made to the trial record:
1. The ethics approval was added.
2. The interventions were changed.
3. The inclusion criteria were changed.
4. The overall end date was changed from 01/12/2021 to 01/09/2021.
5. The recruitment start date was changed from 01/03/2021 to 01/04/2021.
6. The recruitment end date was changed from 01/05/2021 to 01/09/2021.
7. The plain English summary was updated to reflect these changes.
02/02/2021: Trial’s existence confirmed by Alcon Healthcare S.A.
