Acupuncture for eye diseases
| ISRCTN | ISRCTN15071696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15071696 |
| Secondary identifying numbers | 1 |
- Submission date
- 19/07/2021
- Registration date
- 06/09/2021
- Last edited
- 04/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The aim of this study is to assess the association between acupuncture and eye parameters such as intraocular pressure and visual acuity in patients with chronic eye diseases such as open-angle glaucoma and age-related macular degeneration.
Who can participate?
Patients aged over 18 years with stable eye disease
What does the study involve?
Participants are randomly allocated to one of two groups. The participants in the study group will undergo a standardized acupuncture procedure, while the participants in the control will undergo a sham acupuncture procedure, while their regular therapy remains unchanged. There are no drugs applied. The acupuncture sessions are performed weekly for 3 months, and after that every 3 weeks for a total study period of 8 months.
What are the possible benefits and risks of participating?
The possible benefits are an improvement in eye parameters such as intraocular pressure or visual acuity. There is no general risk due to acupuncture.
Where is the study run from?
Ufa Eye Research Institute (Russia)
When is the study starting and how long is it expected to run for?
August 2019 to December 2026
Who is funding the study?
Ufa Eye Research Institute (Russia)
Who is the main contact?
Prof. Mukharram M. Bikbov
Contact information
Scientific
Augenpraxis, Adenauerplatz 2
Heidelberg
69115
Germany
 ORCID ID |
0000-0003-2972-5227 |
|---|---|
| Phone | +49 (0)6221 3929320 |
| Jost.Jonas@medma.uni-heidelberg.de |
Study information
| Study design | Case series study and a randomized controlled masked trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, available upon reasonable request from Jost.Jonas@medma.uni-heidelberg.de |
| Scientific title | Acupuncture and ocular parameters: the Ufa acupuncture study |
| Study acronym | UFaAcuStudy |
| Study objectives | Acupuncture may lead to a change in ocular parameters such as intraocular pressure and visual acuity, and to a change in systemic parameters, such as blood pressure and diabetic metabolic control (blood glucose concentration). |
| Ethics approval(s) | Approved 12/12/2018, the Ethics Committee of the Academic Council of the Ufa Eye Research Institute (90 Pushkin st., Ufa, 450008, Russia; +7 (0)347 286 5303; niipriem@yandex.ru), ref: Protocol No 4 |
| Health condition(s) or problem(s) studied | Ocular diseases such as glaucoma and age-related macular degeneration, and general diseases such as arterial hypertension and diabetes mellitus |
| Intervention | Randomisation will be performed as simple randomization using a random number generator. The participants in the study group will undergo a standardized acupuncture procedure, while the participants in the control will undergo a sham acupuncture procedure, while their regular therapy remains unchanged. There are no drugs applied. The acupuncture sessions are performed weekly for 3 months, and after that every 3 weeks for a total study period of 8 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Intraocular pressure measured by applanation tonometry at all acupuncture sessions performed weekly for 3 months, and after that every 3 weeks for a total study period of 8 months |
| Secondary outcome measures | Visual acuity measured using the best-corrected visual acuity method at all acupuncture sessions performed weekly for 3 months, and after that every 3 weeks for a total study period of 8 months |
| Overall study start date | 01/08/2019 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Age >18 years 2. Not pregnant 3. Able to understand and sign a written informed consent |
| Key exclusion criteria | 1. Age less than 18 years 2. Pregnancy 3. Unable to understand and sign a written informed consent |
| Date of first enrolment | 01/09/2019 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Ufa
450077
Russian Federation
Sponsor information
Hospital/treatment centre
c/o Prof. Mukharram Bikbov
90 Pushkin Street
Ufa
450077
Russian Federation
| Phone | +7 (0)347272 37 75 |
|---|---|
| niipriem@yandex.ru | |
| Website | http://www.ufaeyeinstitute.ru/en/ |
"ROR" |
https://ror.org/04grwn689 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The first results of the pilot study are to be published in late 2021 or 2022. A study protocol will be published together with the first results of a study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Mukharram M. Bikbov, Ufa Eye Research Institute, Pushkin st., Ufa, Russia, 450008. Type of data that will be shared: Any kind of raw microdata. When the data will become available and for how long: when the study is published, for several years. The anonymized data will be shared with anybody requesting them. Consent from participants was obtained. |
Editorial Notes
04/03/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2024 to 31/12/2025.
2. The overall end date was changed from 31/12/2025 to 31/12/2026.
3. The plain English summary was updated to reflect these changes.
02/02/2022: The intention to publish date has been changed from 01/02/2022 to 01/02/2025.
07/09/2021: Internal review.
27/08/2021: Trial's existence confirmed by the Ethics Committee of the Academic Council of the Ufa Eye Research Institute.
