Dry EyeNCT05120401
Causal Relationship Between Dry Eye and Accommodative Spasm
An observational study of Dry Eye, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To investigate the causal relationship of Sicca dry eye patients with presbyopic refractive error and accommodative spasm. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- presbyopia glasses
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Nov 2021to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asian population with dry eye
Who may be able to join
- dry eye
Who cannot join
- under 20 year old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Lin-Chin Elsa Mai, Dr., +886-2-8966-7000 ext. 4271, elsamai@gmail.com
Lin-Chin Elsa Mai, Dr.
About this study
To investigate the causal relationship of Sicca dry eye patients with presbyopic refractive error and accommodative spasm.
Read the 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).
- Conditions
- Dry Eye
- Being tested
- presbyopia glasses
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presbyopia glassesDevice
fogging for glasses for far and intermediate
| Study group | Role | What they receive |
|---|---|---|
| dry eye with presbyopia | dry eye with presbyopia , Intervention : glasses prescrubed Receives: Device: presbyopia glasses | |
| dry eye with presbyopia without glasses use | no glasses use Receives: Device: presbyopia glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve of dry eye / OSDI
OSDI improve
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start5 Nov 2021 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin-Chin Mai, Far Eastern Memorial Hospital
- Investigators
- Elsa LC MAI, MPH, Dr., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120401
- Sponsor's protocol ID
- 110100-E
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Relationship Between Dry Eye and Accommodative Spasm
- ClinicalTrials.gov ID
- NCT05120401
- Acronym / sponsor ID
- 110100-E
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 5 Nov 2021 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the causal relationship of Sicca dry eye patients with presbyopic refractive error and accommodative spasm.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry eye with presbyopia | – | Device: presbyopia glassesdry eye with presbyopia , Intervention : glasses prescrubed |
| dry eye with presbyopia without glasses use | – | Device: presbyopia glassesno glasses use |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asian population with dry eye
Key inclusion criteria (1 listed)
- dry eye
Key exclusion criteria (1 listed)
- under 20 year old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| presbyopia glassesfogging for glasses for far and intermediate | Device | dry eye with presbyopia, dry eye with presbyopia without glasses use |
Primary outcome
Improve of dry eye / OSDI
Time frame: 30 days
OSDI improve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsa LC MAI, MPH, Dr. principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsa LC Mai, MPH, Dr. (886-89667000 ext. 4238, elsamai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve of dry eye / OSDI (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.