Causal Relationship Between Dry Eye and Accommodative Spasm

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05120401

Collaborator

(none)

200

Enrollment

Location

47.3

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Causal Relationship Between Dry Eye and Accommodative Spasm

Anticipated Study Start Date :

Nov 5, 2021

Anticipated Primary Completion Date :

Jul 20, 2024

Anticipated Study Completion Date :

Oct 15, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Improve of dry eye / OSDI [30 days]
OSDI improve

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

dry eye

Exclusion Criteria:

under 20 year old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Far Eastern Memorial Hospital	New Taipei City		Taiwan	220

Sponsors and Collaborators

Far Eastern Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lin-Chin Mai, doctor, Far Eastern Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05120401

Other Study ID Numbers:

110100-E

First Posted:

Nov 15, 2021

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Nov 15, 2021