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A prospective, multicenter clinical trial to evaluate the clinical performance of ophthalmic OCT Image Auxiliary Diagnosis Software for the diagnosis of age-related macular degeneration

A prospective, multicenter clinical trial to evaluate the clinical performance of ophthalmic OCT Image Auxiliary Diagnosis Software for the diagnosis of age-related macular degeneration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065135
Enrollment
Unknown
Registered
2022-10-28
Start date
2022-10-31
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration

Interventions

Gold Standard:Film reading results of senior doctors, that is, senior doctors read the qualified OCT images, and the film reading results are used as the judgment criteria
Index test:Use the test instrument (ophthalmic OCT image auxiliary diagnosis software) to analyze and calculate the collected qualified OCT images, and draw the auxiliary diagnosis conclusion.

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age = 50 years old, regardless of gender; 2) Subjects met any of the following: a) The first patient complained of decreased vision, distorted vision or dark center of vision, and the researcher decided it was suspected Age related macular degeneration exists, which requires further ophthalmic OCT examination; b) Subjects were previously diagnosed with age-related macular degeneration below the middle stage, and required ophthalmic OCT examination Follow up. 3) The subjects voluntarily participated in the trial, with good compliance and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who are not suitable for OCT examination and cannot obtain OCT images; 2) Have a history of retinal laser therapy; 3) People with mental illness who cannot understand the informed consent form; 4) Those who are participating in other clinical trials; 5) The researcher believes that other reasons are not suitable for this clinical trial: for example, eye trauma, unstable body state, photosensitive drugs being used, abnormality in one eye, inability to perform OCT in both eyes, etc.

Design outcomes

Primary

MeasureTime frame
sensitivity;Specificity;

Secondary

MeasureTime frame
positive predictive value;negative predictive value;

Countries

China

Contacts

Public ContactWenChan Wu

No. 270, West College Road, Wenzhou, Zhejiang

wuwencan118@163.com13676759736

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026