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Clinical Study on Objective Quantitative Assessment of Ocular Pain Associated with Dry Eye and Corneal Neuropathic Pain and Multi-omics Analysis of the Ocular Surface

Clinical Study on Objective Quantitative Assessment of Ocular Pain Associated with Dry Eye and Corneal Neuropathic Pain and Multi-omics Analysis of the Ocular Surface

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121556
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Dry eye disease

Interventions

Dry eye with pain group:None
Normal group:None
Corneal neuropathic pain group:None
Dry eye without pain group:None

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–70 years, with no restriction on sex; able to understand and complete questionnaires and undergo relevant examinations; 2. Normal control group: OSDI score = 13 and NIBUT 9 points, corneal staining > 5 points, lid margin staining width >= 2 mm and/or height >= 25%, with an NRS score of 0; 4. Dry eye with pain group: OSDI score >=13 and NIBUT 9 points, corneal staining > 5 points, lid margin staining width >= 2 mm and/or height >=25%, with an NRS score >= 1 and pain duration of at least 3 months; 5. Corneal neuropathic pain group: OSDI score = 1 and pain duration of at least 3 months;

Exclusion criteria

Exclusion criteria: 1.Inability or refusal to provide written informed consent; 2.History of ocular surgery or ocular trauma; 3.Contact lens use within the past 1 month; 4.Immune-related dry eye, allergic conjunctivitis, or pterygium; 5.Ocular surface or corneal infection within the past 3 months; 6.Uveitis or glaucoma; 7.Known allergy to topical ocular agents such as sodium fluorescein, proparacaine, or tobramycin eye drops; 8.Presence of severe systemic diseases; 9. Presence of systemic diseases that significantly affect pain perception (e.g., diabetic neuropathy, multiple sclerosis, postherpetic neuralgia); 10.Use of systemic medications that may affect pain sensitivity within the past 1 month (e.g., opioids, nonsteroidal anti-inflammatory drugs, antidepressants, anticonvulsants);

Design outcomes

Primary

MeasureTime frame
Corneal sensation and corneal mechanical pain threshold;Obital Mechanical Pain Pressure Threshold;

Secondary

MeasureTime frame
Numeric Rating Scale;Ocular Pain Assessment Survey;Schirmer’s Test I;Neuropathic Pain Symptom Inventory–Eye;Corneal fluorescein staining;confocal microscope;Non-Invasive Break-Up Time;Ocular Surface Disease Index;

Countries

China

Contacts

Public ContactZiyan Chen

The Zhongshan Ophthalmic Center,Sun Yat-sen University

chenziyan@gzzoc.com+86 20 66610720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026