Study evaluating the safety and efficacy of YAG laser for the treatment of vitreous opacity
| ISRCTN | ISRCTN12191616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12191616 |
| Secondary identifying numbers | HEBAIER201904 |
- Submission date
- 29/09/2022
- Registration date
- 13/10/2022
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Dots and lines (floaters) or flashes of light in your vision are common. They're usually caused by a harmless process called posterior vitreous detachment (PVD), where the gel inside your eyes changes. Symptomatic vitreous opacities are floaters that are bothersome enough to motivate a patient to seek relief. Symptomatic vitreous floaters significantly and negatively impact quality of life.
Recently Ultra Q Reflex™ neodymium-doped yttrium-aluminum-garnet (YAG) laser vitreolysis is a popular treatment. The objective of this study was to evaluate the efficacy and safety of YAG laser vitreolysis in the treatment of vitreous floaters.
Who can participate?
Patients with symptoms of floaters from a posterior vitreous detachment (PVD).
What does the study involve?
Patients were randomly divided into 2 groups by a random number. Number 1 referred to treatment group, Number 2 referred to un-treatment group (only observation). Patients in treatment group will be installed eye drops for surface anesthesia and pupil dilation before laser treatment. No eye drops will be administered after the laser treatment. A contact lens with eye moisturizer will be used on the surface of the treatment eye to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the disruption of the vitreous opacities into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician. Only one treatment session will be performed. Patients will have intraocular pressure checked before and 30 minutes after procedure.
What are the possible benefits and risks of participating?
It is understood that participation in this study may not derive any direct medical benefits to patients. Patients may have a good response to treatment; however, it is possible that patients may not see an improvement. Information from your participation in this study may benefit persons with symptomatic floaters from posterior vitreous detachment Weiss ring in the future. The risks of YAG laser treatment that occur in about 1 in every 100 patients are an increased eye pressure, glaucoma and cataract formation. Risks that occur in about 1 in every 1000 patients are eye inflammation, retinal tear, retinal detachment, retinal edema, and optic nerve injury. The minor side effects include conjunctival hemorrhage (bleeding outside the eye), eye redness and irritation, headache, or new floaters.
Where is the study run from?
Aier Eye Hospital Group (China)
When is the study starting and how long is it expected to run for?
February 2019 to March 2022
Who is funding the study?
Science Research Foundation of Aier Eye Hospital Group, China (AM1901D1).
Who is the main contact?
Jiannan Liu, lomicheal@163.com
Contact information
Principal Investigator
NO.509 Hayao Road
Harbin
150076
China
 ORCID ID |
0000-0001-8485-254X |
|---|---|
| Phone | +86 18545179547 |
| psmeye@163.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| 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 | Efficacy and safety of YAG laser vitreolysis for symptomatic posterior vitreous detachment |
| Study acronym | ESYLV |
| Study objectives | AG laser vitreolysis is effective and safe for symptomatic posterior vitreous detachment. |
| Ethics approval(s) | Approved 10/02/2019, Harbin Aier Eye Hospital (509 Haoyao Street, Harbin, China; +86 045188810988; 39166163@qq.com), ref: HEBAIER2019IRB06 |
| Health condition(s) or problem(s) studied | Treatment of symptomatic posterior vitreous detachment via YAG laser vitreolysis. |
| Intervention | Randomization was achieved by employing a random number for each patient, 1 for treatment and 2 for control. Patients in treatment group will be dilated with phenylephrine 2.5% and tropicamide 1% and proparacaine prior to YAG laser. No postoperative eye drops will be administered. A Karickoff lens with goniosol will be used to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the disruption of the Weiss ring into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician. Only one treatment session will be performed. Patients will have intraocular pressure checked by applanation onometry before and 30 minutes post-procedure. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | At preoperative, postoperative week 1, month 1, month 3 and month 6: 1. Visual disturbance measured using a 10-point visual disturbance score (with 0 being asymptomatic and 10 indicating impairing symptoms) 2. Degree of patients disturbed by floaters measured using a short questionnaire of 4-degree floater symptoms 3. Symptoms improvement percentage measured using a 4-level qualitative scale |
| Secondary outcome measures | At preoperative, postoperative week 1, month 1, month 3 and month 6: 1. The National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) 2. Best corrected visual acuity (BCVA) |
| Overall study start date | 10/02/2019 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 306 |
| Key inclusion criteria | Current inclusion criteria as of 14/11/2022: 1. Symptomatic vitreous opacities owing to complete PVD (Weiss ring), symptoms for at least 3 months 2. No sensation of flashing for at least 2 weeks 3. Clear optical media 4. The distance between floaters and retina or lens was over 3mm (measured by B-scan ultrasound) 5. The 10-point visual disturbance score of at least 4 6. Ability to undertake YAG laser procedure 7. Acceptance of related risks _____ Previous inclusion criteria: 1. Symptomatic vitreous opacities owing to complete PVD (Weiss ring), symptoms for at least 3 months 2. Clear optical media 3. The distance between floaters and retina or lens was over 3mm (measured by B-scan ultrasound) 4. The 10-point visual disturbance score at least 4 5. Ability to undertake YAG laser procedure 6. Acceptance of related risks |
| Key exclusion criteria | Current exclusion criteria as of 11/11/2022: 1. Snellen BCVA was worse than 20/50 2. Patients with a history of glaucoma, severe cataract, vitreous hemorrhage, retinal disease, macular disease. _____ Previous exclusion criteria as of 18/10/2022: 1. Snellen BCVA was worse than 20/50 2. Less than 50% of the Weiss ring was ablated after one treatment (objective changes were evaluated by the surgeon who performed the YAG laser vitreolysis); patients with a history of glaucoma, severe cataract, vitreous hemorrhage, retinal disease, macular disease. _____ Previous exclusion criteria: 1. Snellen BCVA was worse than 20/50 2. Eyes with intraocular lens (IOL) 3. Less than 50% of the Weiss ring was ablated after one treatment (objective changes were evaluated by the surgeon who performed the YAG laser vitreolysis); patients with a history of glaucoma, severe cataract, vitreous hemorrhage, retinal disease, macular disease. |
| Date of first enrolment | 08/10/2019 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Harbin
150076
China
Sponsor information
Hospital/treatment centre
NO. 509 Haoyao Road
Harbin
150076
China
| Phone | +86 045188810988 |
|---|---|
| 391667163@qq.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| 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 jouranl. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 12/10/2022 | No | No |
Additional files
Editorial Notes
14/11/2022: The inclusion criteria were changed.
11/11/2022: The following changes were made to the trial record:
1. The exclusion criteria was changed from 01/11/2022 to 01/03/2023.
2. The intention to publish date
18/10/2022: The exclusion criteria were changed.
12/10/2022: Trial's existence confirmed by Harbin Aier Eye Hospital.
