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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in China

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 groups in NCT06763822
Study groupRoleWhat they receive
dry eyeExperimentalNot described
Receives: Behavioral: close eyes; Behavioral: cold compress
non-dry eye groupPlacebo comparatorNot 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.

  1. 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.

  1. First posted8 Jan 2025
  2. Study start16 Jun 2024
  3. Primary completion2 Aug 2024
  4. Study completion24 Oct 2024

Resources

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)
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

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.

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