Causal Relationship Between Dry Eye and Accommodative Spasm

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Device: presbyopia glasses

Detailed 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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Elsa LC Mai, MPH, Dr.; Phone Number: 4238 886-89667000; Email: elsamai@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 220
    • Recruiting
    • Far Eastern Memorial Hospital
    • Contact: Lin-Chin Elsa Mai, Dr.; Phone Number: 4271 +886-2-8966-7000; Email: elsamai@gmail.com
    • Principal Investigator: Lin-Chin Elsa Mai, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asian population with dry eye

Description

Inclusion Criteria:

- dry eye

Exclusion Criteria:

• under 20 year old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dry eye with presbyopia; dry eye with presbyopia , Intervention : glasses prescrubed	Device: presbyopia glasses; fogging for glasses for far and intermediate
dry eye with presbyopia without glasses use; no glasses use	Device: presbyopia glasses; fogging for glasses for far and intermediate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve of dry eye / OSDI	OSDI improve	30 days

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Elsa LC MAI, MPH, Dr., Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 5, 2021
• Primary Completion (Anticipated): July 20, 2024
• Study Completion (Anticipated): October 15, 2025

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 110100-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No