Exploring the Landscape of Optic Neuropathy and Vasculopathy: the LOVE study
| ISRCTN | ISRCTN99411112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99411112 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | LOVE-2024-v1 |
| Sponsor | National Sun Yat-sen University |
| Funder | Science and Technology Projects in Guangzhou (China) |
- Submission date
- 26/03/2024
- Registration date
- 03/04/2024
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Diabetic retinopathy neuropathy (DRN) is the term used to describe the initial degeneration of nerve cells in the retina (the light-sensitive tissue at the back of the eye) due to elevated levels of blood sugar. However, the precise mechanism behind this condition remains unclear. This study seeks to investigate how DRN progresses by using various imaging techniques to examine the eye.
Who can participate?
Individuals aged 18 years and older with and without diabetes who live in Guangzhou, China
What does the study involve?
Comprehensive eye and general tests are performed every 2 years over a period of 4 years. Participants receive comprehensive eye and general tests and one-on-one ophthalmologist consultations based on the exam results. All the exams follow the normal clinical operation.
What are the possible benefits and risks of participating?
Participants benefit from receiving comprehensive eye and general tests and one-on-one ophthalmologist consultations based on the results. No additional risks are anticipated as all the exams follow the normal clinical operation.
Where is the study run from?
Zhongshan Ophthalmic Center, Sun Yat-sen University (China)
When is the study starting and how long is it expected to run for?
December 2023 to December 2027
Who is funding the study?
Science and Technology Projects in Guangzhou (China)
Who is the main contact?
Dr Wei Wang, wangwei@gzzoc.com
Contact information
Public, Scientific, Principal investigator
No. 54 Xianlie Nan Road
Yuexiu District
Guangzhou
510060
China
| Phone | +86 (0)20 87334687 |
|---|---|
| wangwei@gzzoc.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective and prospective ambispective cohort study |
| Secondary study design | Cohort study |
| Scientific title | Landscape of optic neuropathy and vasculopathy evolution (LOVE) study |
| Study acronym | LOVE |
| Study objectives | To explore the longitudinal trajectory and key metabolic markers of diabetic optic neurodegeneration based on large population cohorts and multimodal ocular imaging in vivo |
| Ethics approval(s) |
Approved 08/01/2024, Zhongshan Ophthalmic Center Ethics Committee of Sun Yat-sen University (No. 7 Jinsui Road, Zhujiang New Town, Guangzhou, 510060, China; +86 (0)20 87332529; zocethics@163.com), ref: 2024KYPJ003 |
| Health condition(s) or problem(s) studied | Optic neuropathy in individuals with diabetes |
| Intervention | The LOVE study is a retrospective and prospective ambispective cohort study, including individuals with and without diabetes who attend Zhongshan Ophthalmic Center (ZOC) screening. All individuals in this study will be followed up every 2 years over a continuous period of 4 years. The examinations include questionnaire surveys, general physical examinations, blood sample collection, regular ocular examinations (such as intraocular pressure, refraction), (ultra-widefield) optical coherence tomography (OCT), ultra-widefield OCT angiography (OCTA), and (ultra-widefield) fundus photography. |
| Intervention type | Other |
| Primary outcome measure(s) |
Longitudinal change of peripapillary retinal nerve fiber layer thickness measured using optical coherence tomography (OCT) in eligible participants at baseline and each follow-up visit (2 and 4 years) |
| Key secondary outcome measure(s) |
1. Longitudinal change of macular ganglion cell-inner plexiform layer (GCIPL) thickness measured using optical coherence tomography (OCT) in eligible participants at baseline and each follow-up visit (2 and 4 years) |
| Completion date | 30/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1200 |
| Key inclusion criteria | 1. Community-registered patients with diabetes 2. Individuals who live in Guangzhou for more than 6 months 3. Aged 18 years and older 4. Individuals who are capable of cooperating with ocular examinations and meeting quality standards 5. Individuals who voluntarily participate in this study 6. Individuals who do not participate in other trials or treatments aimed at preventing or delaying the onset and progression of diabetic retinopathy (DR) 7. Absence of retinal lesions, or retinal/macular lesions not meeting the positive criteria for referable DR |
| Key exclusion criteria | 1. Individuals who cannot cooperate with examinations |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 30/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Yuexiu District
Guangzhou
510060
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Wei Wang (wangwei@gzzoc.com). Informed consent will be obtained before the participant joins the study. The study will follow the legal restrictions of the Ethics Committee of Zhongshan Ophthalmic Center, Sun Yat-sen University. For access to the data, please contact the principal investigator after the study is completed. |
Editorial Notes
04/04/2024: The public title was changed from "Exploring the landscape of optic neuropathy and vasculopathy" to "Exploring the Landscape of Optic Neuropathy and Vasculopathy: the LOVE study".
26/03/2024: Study's existence confirmed by the Zhongshan Ophthalmic Center Ethics Committee of Sun Yat-sen University.
