Neuropathic Corneal Pain
Conditions
Interventions
Control Group:Instillation of placebo sodium chloride eye drops
Experimental Group:Instillation of autologous serum eye drops
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Presence of neuropathic pain or neuropathic-like symptoms (e.g., burning sensation, stabbing pain, foreign body sensation, electric shock-like pain, and light-evoked pain) lasting for more than 3 months, with a pain intensity score of >=4 on the Visual Analog Scale (VAS); 2. Eye pain not fully relieved by conventional treatment (artificial tears and anti-inflammatory therapy); 3. Clinical examination showing an Oxford score =18 years; 7. Patient must meet all requirements for informed consent. Prior to any study-related procedure, the patient and/or their legal representative must read the informed consent document, and sign and date it; 8. The patient must be capable and willing to comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Exclusion of any concurrent ocular conditions associated with ocular pain, including corneal infections, abrasions, recurrent corneal erosion syndrome, iridocyclitis, or uveitis; 2.Exclusion of contact lens or scleral lens use within half-month prior to enrollment; 3.Severe meibomian gland dysfunction (MGD); 4.Inability to complete standardized questionnaires; 5.Current use of topical ophthalmic agents affecting corneal or ocular surface integrity, or inability to discontinue such medications during the study period; 6.Comorbid systemic or ocular disorders predisposing to corneal neuropathy, including diabetes mellitus, Sjögren’s syndrome, graft-versus-host disease (GVHD), or other autoimmune diseases; 7.Systemic contraindications to autologous serum eye drop (ASED) preparation, such as: Unstable angina pectoris,recent (<6 months) myocardial infarction or cerebrovascular accident,severe peptic ulcer disease (gastric/duodenal),pancreatitis,acute/chronic renal insufficiency,hematologic disorders,active infectious diseases (local or systemic),malignancies or clinically significant benign tumors,minor surgeries (e.g., tooth extraction) within 14 days,intermediate surgeries (e.g., appendectomy, herniorrhaphy, tonsillectomy) within 3 months,major organ surgeries (cardiac, hepatic, renal) within 6 months; 8.Pregnancy or lactation; 9.Advanced age or frailty with compromised tolerance to phlebotomy-associated blood loss. 10.Patients with a history of systemic pharmacological therapy for neuropathic ocular pain within the 3-month period preceding enrollment shall be excluded;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ocular Pain Intensity from Baseline at 12 Weeks of Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in OSDI Questionnaire Score from Baseline at the 12-Week Follow-up Visit;Changes in Corneal Nerve Density, Tortuosity, and Nerve Bead Density from Baseline;Change in Ocular Pain-Related Symptoms from Baseline;Change in Corneal Sensitivity from Baseline;Change in Ocular Pain Score from Baseline after 4 Weeks of Treatment;Change in Tear Film Break-Up Time (TBUT) from Baseline; | — |
Countries
China
Contacts
Public ContactWang Haiou
Eye Hospital, Wenzhou Medical University
Outcome results
None listed