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NCT05120401 Clinical Trial

Causal Relationship Between Dry Eye and Accommodative Spasm

Dry Eye Clinical Trial

Official title:
Causal Relationship Between Dry Eye and Accommodative Spasm

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05120401
Other study ID # 110100-E
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2021
Est. completion date October 15, 2025

Study information
Verified date November 2021
Source Far Eastern Memorial Hospital
Contact Elsa LC Mai, MPH, Dr.
Phone 886-89667000
Email elsamai@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the causal relationship of Sicca dry eye patients with presbyopic refractive error and accommodative spasm.

Description:

Dry eye is a disease of the ocular surface. Severe dry eye produce symptom of discomfort in and around the eye that drastically affect life quality of the patient. OSDI index is retrieve from a questionnaire specific for these dry eye symptoms, it is an internationally accepted level to reveal the severity of Dry eye disease. One part of the symptom is pain and soreness around the eye. Hyperalgesia is an increase response to a stressful/ noxious stimulus whereas allodynia is a painful response to a normally innocuous stimulus. Our hypothesis state that Sicca Dry eye upregulated inflammatory cytokine in the eye has pre-sensitized the nociceptor nerve fiber in the cornea and orbit, therefore the normally innocuous effort of accommodation and ciliary muscle contraction produce intolerable retro-orbital eye pain, which drives the patient to seek medical attention, on presentations these patient show an elevated OSDI and Pain Index (PI).

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date October 15, 2025
Est. primary completion date July 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 99 Years
Eligibility Inclusion Criteria: - dry eye Exclusion Criteria: - under 20 year old

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• presbyopia glasses
fogging for glasses for far and intermediate

Locations
Country Name City State
Taiwan Far Eastern Memorial Hospital New Taipei City

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improve of dry eye / OSDI OSDI improve 30 days
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