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CompletedNCT06763822Updated Jan 8, 2025

Dry Eye and Asthenopia Treatment Effect Evaluation.

An interventional study of close eyes and cold compress in Dry Eye and Asthenopia, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dry Eye
  • Asthenopia
03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's enrollment of 55 is close to the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    dry eye

    Behavioral: close eyes · Behavioral: cold compress

  • Placebo comparator
    non-dry eye group

    Behavioral: close eyes · Behavioral: cold compress

Interventions

  • Behavioralclose eyes

    ask participants to close their eyes for rest

  • Behavioralcold compress

    cold compress on participants' eyes for rest

06

What researchers measure

Primary outcomes

  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

    Time frame: 1 hour

07

Study locations

1 site
  • The Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU)
    Hangzhou, Zhejiang 310000, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Aug 2024, 1 month.

Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 1 month is below that.

Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2024
First posted
Jan 8, 2025
StartActual
Jun 16, 2024
Primary completionActual
Aug 2, 2024
CompletionActual
Oct 24, 2024
Last update
Jan 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06763822
Responsible party
Sponsor
First posted
Jan 8, 2025
Start date
Jun 16, 2024
Primary completion
Aug 2, 2024
Completion
Oct 24, 2024
Last update
Jan 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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