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Handheld Electrophysiology for Glaucoma Evaluation

Application of Handheld Electrophysiological Testing in the Evaluation of Glaucoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600131834
Enrollment
Unknown
Registered
2026-09-07
Start date
2026-10-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

glaucoma

Interventions

Control group:None

Sponsors

Eye & ENT hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with Glaucoma (for Part 1: correlation study, and Part 2: pre- and postoperative study): 1. Aged >= 18 years, with no restriction on sex; 2. Clinically diagnosed with glaucoma based on ophthalmic examinations. The diagnostic criteria refer to the Chinese Glaucoma Guidelines (2020) issued by the Glaucoma Group of the Chinese Ophthalmological Society, Chinese Medical Association, and include: (1) Characteristic glaucomatous optic nerve damage, such as enlarged optic disc cupping, thinning of the neuroretinal rim, and retinal nerve fiber layer defects; (2) Corresponding visual field defects, with visual field test results consistent with glaucomatous visual field damage, such as arcuate scotoma, paracentral scotoma, or tubular visual field; (3) Exclusion of optic neuropathy caused by other reasons; 3. For Part 2, the pre- and postoperative study, patients should be scheduled to undergo or have already undergone anti-glaucoma surgery, including but not limited to trabeculectomy, glaucoma drainage valve implantation, and minimally invasive glaucoma surgery; 4. Agree to participate in this study and sign the informed consent form. Healthy Controls (for Part 1: correlation study only): 1. Aged >= 18 years, with no restriction on sex; 2. Best-corrected visual acuity >= 0.8; 3. Intraocular pressure <= 21 mmHg; 4. No family history of glaucoma among first-degree relatives within three generations; 5. No history of ocular surgery, except for refractive surgery; 6. No known ocular diseases, including but not limited to diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, retinitis pigmentosa, uveitis, or optic nerve diseases; 7. No systemic diseases affecting retinal function, such as diabetes mellitus or hypertensive retinopathy; 8. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Applicable to All Study Participants: 1. Other optic nerve diseases besides glaucoma, such as ischemic optic neuropathy, optic neuritis, compressive optic neuropathy, or Leber hereditary optic neuropathy; 2. Severe retinal diseases, such as diabetic retinopathy, retinal vein occlusion, retinal detachment, macular degeneration, or retinitis pigmentosa; 3. Severe corneal diseases, such as corneal opacity, corneal dystrophy, or keratoconus, or severe lens opacity such as severe cataract, which may affect retinal light stimulation and signal recording; 4. History of ocular trauma or ocular surgery, except for glaucoma surgery; patients who underwent refractive surgery more than 6 months previously may be included after evaluation; 5. High myopia, defined as spherical equivalent <= -6.0 D, because high myopia itself may alter ERG parameters; 6. Intraocular infection or active ocular inflammation, such as conjunctivitis, keratitis, or uveitis; 7. History of photosensitive epilepsy, because flash stimulation is used during ERG testing; 8. Eyelid or orbital structural abnormalities that prevent proper placement of the sensor strip electrode, such as eyelid defects, blepharospasm, or orbital fracture; 9. Severe systemic diseases, such as uncontrolled hypertension, severe heart disease, hepatic or renal failure, or hematologic diseases, that may affect retinal blood circulation or cooperation during examinations; 10. Cognitive impairment or psychiatric disorders that prevent cooperation with RETeval ERG testing, visual field testing, or OCT examination; 11. Pregnancy or lactation, because physiological changes during pregnancy may affect the accuracy of visual function assessment, and this study does not involve direct benefit to pregnant women; 12. Current participation in another interventional clinical study. Additional Exclusion Criteria for Healthy Controls: 1. Any known history of glaucoma or ocular hypertension; 2. Any known history of retinal or optic nerve diseases; 3. Previous treatment with anti-glaucoma medications; 4. Presence of glaucomatous visual field defects or optic nerve damage.

Design outcomes

Primary

MeasureTime frame
Electrophysiological parameters recorded by RETeval ERG;

Countries

China

Contacts

Public ContactKong Xiangmei

Eye & ENT hospital of Fudan University

xiangmei.kong@fdeent.org+86 21 64377134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026