Dry EyeNCT04043949
The Influences of Dry Eye Disease on Optical Quality
An observational study of Dry Eye and Vision; Disturbance, Hysterical, run by Peking University Third Hospital at 1 site in China.
Trial summary
DED could result in visual disturbance and damage optical quality. We aimed to evaluate the influences of dry eye disease (DED) on optical quality and their correlations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye, Vision; Disturbance, Hysterical
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Jul 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aged between 18-65 years old.
Who may be able to join
- patients were diagnosed as dry eye according to the criteria provided by the Dry Eye Workshop (DEWS)
- positive corneal fluorescein staining (CFS)
- best-corrected distance visual acuity better than 20/20.
Who cannot join
- History of ocular surgeries, contact lens wear, meibomian gland dysfunction, and any type of corneal scarring such as dystrophies or infections.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
DED could result in visual disturbance and damage optical quality. We aimed to evaluate the influences of dry eye disease (DED) on optical quality and their correlations.
Read the detailed description
This study is aimed at evaluating changes of optical quality in dry eye patients with superficial punctate keratopathy after being treated by artificial lubricant and anti-inflammatory eye drops.
- Conditions
- Dry Eye, Vision; Disturbance, Hysterical
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal | healthy subjects | |
| Dry eye group | patients with dry eye | |
| Dry eye after treatment | patients with dry eye after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of DED influenced the optical quality of dry eye patients
The optical quality of dry eye patients
Measured: 2017.7-2019.7
High order abberations
cornela high order abberations of patients
Measured: 2017.7-2019.7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, MD,Phd, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043949
- Sponsor's protocol ID
- DEDOQ
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Dry Eye Disease on Optical Quality
- ClinicalTrials.gov ID
- NCT04043949
- Acronym / sponsor ID
- DEDOQ
- Conditions
- Dry Eye, Vision; Disturbance, Hysterical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 2 Aug 2019 (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.
DED could result in visual disturbance and damage optical quality. We aimed to evaluate the influences of dry eye disease (DED) on optical quality and their correlations.
Detailed description
This study is aimed at evaluating changes of optical quality in dry eye patients with superficial punctate keratopathy after being treated by artificial lubricant and anti-inflammatory eye drops.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –healthy subjects |
| Dry eye group | – | –patients with dry eye |
| Dry eye after treatment | – | –patients with dry eye after treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aged between 18-65 years old.
Key inclusion criteria (3 listed)
- patients were diagnosed as dry eye according to the criteria provided by the Dry Eye Workshop (DEWS)
- positive corneal fluorescein staining (CFS)
- best-corrected distance visual acuity better than 20/20.
Key exclusion criteria (1 listed)
- History of ocular surgeries, contact lens wear, meibomian gland dysfunction, and any type of corneal scarring such as dystrophies or infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The severity of DED influenced the optical quality of dry eye patients
Time frame: 2017.7-2019.7
The optical quality of dry eye patients
High order abberations
Time frame: 2017.7-2019.7
cornela high order abberations of patients
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 2 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Hong Qi, MD,Phd study chair
Peking University Third 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 and Vision; Disturbance, Hysterical, run by Peking University Third Hospital 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 3 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 2 Aug 2019. 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. 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?
The severity of DED influenced the optical quality of dry eye patients (time frame: 2017.7-2019.7). The study lists 2 primary outcomes in all. 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 2 Aug 2019.