Dry EyeNCT06763822
Dry Eye and Asthenopia Treatment Effect Evaluation.
A study testing close eyes and cold compress in people with Dry Eye and Asthenopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Asthenopia is a group of syndroms in which the human eye can see more than its visual function can bear due to various causes, resulting in visual disorders, eye discomfort or systemic symptoms after the use of the eyes, and thus can not perform visual work normally, including pain around the eyes and orbit, blurred… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Asthenopia
- What is being tested?
- close eyes and cold compress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2024to 24 Oct 2024
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- have basic reading comprehension skills and to be older than 18 years old. not have myopia degree exceeding -6.0D, hyperopia exceeding +2.0D, astigmatism degree exceeding 2.0D, or anisometropia exceeding 2.0D
Who cannot join
- presbyopia or decreased regulation function, ocular inflammation and disease, worn contact lens within 1 month, history of eye surgery within 6 months, lactating or pregnant woman, have severe systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang, 310000
About this study
Official title: Evaluation of Treatment Effect in Patients with Dry Eye Combined with Asthenopia.
Asthenopia is a group of syndroms in which the human eye can see more than its visual function can bear due to various causes, resulting in visual disorders, eye discomfort or systemic symptoms after the use of the eyes, and thus can not perform visual work normally, including pain around the eyes and orbit, blurred vision, dry eyes, tears, etc. In severe cases, headache, nausea, vertigo, etc. Belonging to a group of fatigue syndromes, has become a common problem plaguing contemporary people. The International Tear Film and Ocular Surface Association (TFOS) reported in April 2023 that the incidence of digital ocular tension is as high as 97%. Refractive errors, presbyopia, eye surgery, long-term use of video terminals and dry eyes are the main causes of visual fatigue. But for a long time, the study of visual fatigue relies more on subjective questionnaires and lacks objective indicators. The ciliary muscle of the eye is an important target for improving the regulation function, and it is also a key part affecting visual fatigue. The abnormal regulation of the ciliary muscle is considered to be involved in the mechanism of visual fatigue. accommodative microfluctuations (AMFs) are the uncontrolled fluctuations of the human eye when it fixates on a stationary object or visual icon, with a range of about 0.10D to 0.50D. It is divided into low frequency component (LFC, <0.6Hz) and high frequency component (HFC, 1.0-2.3Hz). The low frequency component is considered to be the adjustment of different focusing distances. The high frequency part is the shaking of the lens, representing the tremor of the ciliary muscle. Literature studies have shown that HFC may be an objective indicator of visual fatigue, and higher HFC usually represents visual fatigue.
According to the report of TFO DEWS II (New International Consensus on Dry Eye), dry eye is defined as a multifactorial ocular surface disease, characterized by the imbalance of tear film structure and function, accompanied by tear film instability, elevated tear osmotic pressure, ocular surface inflammation and damage, abnormal neurosensory function and other symptoms. Dry eye with asthenopia is the most common mixed asthenopia, and the symptoms are more severe. Factors such as astigmatism and refractive correction affect tear film adhesion, resulting in uneven distribution of tear film and shortening of tear film. Poor tear film quality will affect the retinal image quality, the eye to correct this retinal imaging ambiguity and efforts to adjust, long-term impact will appear visual fatigue, tear film instability and visual fatigue affect each other, forming a vicious cycle. Studies have shown that dry eye patients with short tear film rupture time (BUT) are more likely to complain of visual fatigue, and their HFC and visual function are worse. With the improvement of BUT after treatment, the symptoms of dry eye and visual fatigue are reduced, and HFC and visual fluctuation are improved, which proves the possible relationship between HFC and short BUT dry eye.
We hope to conduct a study on HFC in patients with dry eye accompanied by visual fatigue symptoms, clarify the correlation between HFC and different symptoms, signs, severity, and classification of dry eye symptoms, determine whether HFC can be used as one of the indicators of diagnosis and prognosis of dry eye disease, and depict the curve of visual fatigue and working time in different populations. The aim is to provide a new idea for clinical treatment of dry eye.
- Conditions
- Dry Eye, Asthenopia
- Being tested
- close eyes, cold compress
- Medical subject headings
- Dry Eye Syndromes, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
close eyesBehavioural
ask participants to close their eyes for rest
cold compressBehavioural
cold compress on participants' eyes for rest
| Study group | Role | What they receive |
|---|---|---|
| dry eye | Experimental | Not described Receives: Behavioral: close eyes; Behavioral: cold compress |
| non-dry eye group | Placebo comparator | Not described Receives: Behavioral: close eyes; Behavioral: cold compress |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFC (high frequency component)
This study enrolled a total of 27 volunteers with dry eye and 28 volunteers without dry eye. Participants were instructed to read the text content on a tablet computer at a distance of 33.3 cm for 40 min. We measured the high-frequency components (HFC) of accommodation microfluxations to indicate the degree of asthenopia before reading, 10 minutes, 20 minutes, and 40 minutes after reading, respectively to draw the excitation curve. While detecting the recovery curve, we reorganize the participants into closed eye rest group (of 29 participants) and cold compress rest group (of 26 participants). We measured the HFC after 40 minutes of reading as starting point, and then measured the HFC after 5minutes and 15minutes of rest to draw the recovery curve.We conducted linear regression analysis to detect the high-risk factors related to asthenopia.
Two dominant frequencies were revealed by power spectrum analysis of the microfluctuations waveform, including a low-frequency component (LFC) of
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start16 Jun 2024
- Primary completion2 Aug 2024
- Study completion24 Oct 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763822
- Sponsor's protocol ID
- 2024-0089
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Effect in Patients with Dry Eye Combined with Asthenopia.
- ClinicalTrials.gov ID
- NCT06763822
- Acronym / sponsor ID
- 2024-0089
- Conditions
- Dry Eye, Asthenopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 8 Jan 2025 (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.
Asthenopia is a group of syndroms in which the human eye can see more than its visual function can bear due to various causes, resulting in visual disorders, eye discomfort or systemic symptoms after the use of the eyes, and thus can not perform visual work normally, including pain around the eyes and orbit, blurred vision, dry eyes, tears, etc. In severe cases, headache, nausea, vertigo, etc. Belonging to a group of fatigue syndromes, has become a common problem plaguing contemporary people. The International Tear Film and Ocular Surface Association (TFOS) reported in April 2023 that the incidence of digital ocular tension is as high as 97%. Refractive errors, presbyopia, eye surgery, long-term use of video terminals and dry eyes are the main causes of visual fatigue. But for a long time, the study of visual fatigue relies more on subjective questionnaires and lacks objective indicators. The ciliary muscle of the eye is an important target for improving the regulation function, and it is also a key part affecting visual fatigue. The abnormal regulation of the ciliary muscle is considered to be involved in the mechanism of visual fatigue. accommodative microfluctuations (AMFs) are the uncontrolled fluctuations of the human eye when it fixates on a stationary object or visual icon, with a range of about 0.10D to 0.50D. It is divided into low frequency component (LFC, <0.6Hz) and high frequency component (HFC, 1.0-2.3Hz). The low frequency component is considered to be the adjustment of different focusing distances. The high frequency part is the shaking of the lens, representing the tremor of the ciliary muscle. Literature studies have shown that HFC may be an objective indicator of visual fatigue, and higher HFC usually represents visual fatigue.
According to the report of TFO DEWS II (New International Consensus on Dry Eye), dry eye is defined as a multifactorial ocular surface disease, characterized by the imbalance of tear film structure and function, accompanied by tear film instability, elevated tear osmotic pressure, ocular surface inflammation and damage, abnormal neurosensory function and other symptoms. Dry eye with asthenopia is the most common mixed asthenopia, and the symptoms are more severe. Factors such as astigmatism and refractive correction affect tear film adhesion, resulting in uneven distribution of tear film and shortening of tear film. Poor tear film quality will affect the retinal image quality, the eye to correct this retinal imaging ambiguity and efforts to adjust, long-term impact will appear visual fatigue, tear film instability and visual fatigue affect each other, forming a vicious cycle. Studies have shown that dry eye patients with short tear film rupture time (BUT) are more likely to complain of visual fatigue, and their HFC and visual function are worse. With the improvement of BUT after treatment, the symptoms of dry eye and visual fatigue are reduced, and HFC and visual fluctuation are improved, which proves the possible relationship between HFC and short BUT dry eye.
We hope to conduct a study on HFC in patients with dry eye accompanied by visual fatigue symptoms, clarify the correlation between HFC and different symptoms, signs, severity, and classification of dry eye symptoms, determine whether HFC can be used as one of the indicators of diagnosis and prognosis of dry eye disease, and depict the curve of visual fatigue and working time in different populations. The aim is to provide a new idea for clinical treatment of dry eye.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry eye | Experimental | Behavioral: close eyes, Behavioral: cold compress |
| non-dry eye group | Placebo comparator | Behavioral: close eyes, Behavioral: cold compress |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- have basic reading comprehension skills and to be older than 18 years old. not have myopia degree exceeding -6.0D, hyperopia exceeding +2.0D, astigmatism degree exceeding 2.0D, or anisometropia exceeding 2.0D
Key exclusion criteria (1 listed)
- presbyopia or decreased regulation function, ocular inflammation and disease, worn contact lens within 1 month, history of eye surgery within 6 months, lactating or pregnant woman, have severe systemic diseases.
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 |
|---|---|---|
| close eyesask participants to close their eyes for rest | Behavioural | dry eye, non-dry eye group |
| cold compresscold compress on participants' eyes for rest | Behavioural | dry eye, non-dry eye group |
Primary outcome
HFC (high frequency component)
Time frame: 1 hour
This study enrolled a total of 27 volunteers with dry eye and 28 volunteers without dry eye. Participants were instructed to read the text content on a tablet computer at a distance of 33.3 cm for 40 min. We measured the high-frequency components (HFC) of accommodation microfluxations to indicate the degree of asthenopia before reading, 10 minutes, 20 minutes, and 40 minutes after reading, respectively to draw the excitation curve. While detecting the recovery curve, we reorganize the participants into closed eye rest group (of 29 participants) and cold compress rest group (of 26 participants). We measured the HFC after 40 minutes of reading as starting point, and then measured the HFC after 5minutes and 15minutes of rest to draw the recovery curve.We conducted linear regression analysis to detect the high-risk factors related to asthenopia. Two dominant frequencies were revealed by power spectrum analysis of the microfluctuations waveform, including a low-frequency component (LFC) of
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing close eyes and cold compress in people with Dry Eye and Asthenopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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: finished, as of the sponsor's last update on 8 Jan 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFC (high frequency component) (time frame: 1 hour). 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 8 Jan 2025.