Dry EyeNCT06158906
Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
An observational study of Dry Eye, run by He Eye Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the validity of the Chinese translation version of OSDI-6 (C-OSDI-6) in a theoretical set-up of two questionnaire groups for dry eye Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dry Eye
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 17 Feb 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with dry eye
Who may be able to join
- Diagnosed dry eye
- Able and willing to comply with the schedule
- Able to read and understand the C-OSDI-12 questionnaire independently
Who cannot join
- The researchers judged to be not suitable
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the validity of the Chinese translation version of OSDI-6 (C-OSDI-6) in a theoretical set-up of two questionnaire groups for dry eye
Read the detailed description
Screening for dry eye symptoms and quantifying dry eye symptoms aids in assessment, diagnosis, and treatment. Patient-reported outcome (PRO) instruments such as the Ocular Surface Disease Index (OSDI-12) are utilized for assessing patients' subjective experiences and functional abilities. The OSDI-12 comprises of 12-item and is often used in conjunction with other tests in clinical settings to assess individuals with DE. Created in 1997, the original OSDI consisted of 12 items and was designed to evaluate subjective dry eye symptoms and the consequences of DED on vision-related activities of daily life over the preceding week. The 12 items are grouped into three subscales: ocular symptoms (three items), vision-related functions (six items), and environmental triggers (three items). While the original version of the OSDI-12 questionnaire was created in English and was later translated and validated into other languages, it should be used carefully since the cutoff values vary among various languages (27.2 points for the Chinese version and 36.3 points for the Japanese version) . Recent research using Rasch analysis found that separating answer items into four categories by merging "half of the time" and "most of the time" might lead to higher thresholds and better intervals in each category. The OSDI-12 total score is calculated using the formula: [(sum of scores for all questions answered) × 100]/ [(total number of questions answered) × 4]. Ocular Surface Disease Index-6 (OSDI-6) is a derivative and shortened version of the original OSDI-12 and can potentially improve efficiency in a busy clinical setting.
- Conditions
- Dry Eye
- Keywords
- qestionnaire
- 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 |
|---|---|---|
| Study group | Dry eye patients were recruited to fill in the questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI12
The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Dec 2023
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158906
- Sponsor's protocol ID
- OSDI6
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20.
PubMed 28736343Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
PubMed 28736335Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
PubMed 10815152Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.
PubMed 12131034Lu F, Tao A, Hu Y, Tao W, Lu P. Evaluation of Reliability and Validity of Three Common Dry Eye Questionnaires in Chinese. J Ophthalmol. 2018 Aug 27;2018:2401213. doi: 10.1155/2018/2401213. eCollection 2018.
PubMed 30225139Midorikawa-Inomata A, Inomata T, Nojiri S, Nakamura M, Iwagami M, Fujimoto K, Okumura Y, Iwata N, Eguchi A, Hasegawa H, Kinouchi H, Murakami A, Kobayashi H. Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease. BMJ Open. 2019 Nov 25;9(11):e033940. doi: 10.1136/bmjopen-2019-033940.
PubMed 31772113
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
- ClinicalTrials.gov ID
- NCT06158906
- Acronym / sponsor ID
- OSDI6
- Conditions
- Dry Eye
- Keywords
- qestionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 6 Dec 2023 (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.
This study aimed to evaluate the validity of the Chinese translation version of OSDI-6 (C-OSDI-6) in a theoretical set-up of two questionnaire groups for dry eye
Detailed description
Screening for dry eye symptoms and quantifying dry eye symptoms aids in assessment, diagnosis, and treatment. Patient-reported outcome (PRO) instruments such as the Ocular Surface Disease Index (OSDI-12) are utilized for assessing patients' subjective experiences and functional abilities. The OSDI-12 comprises of 12-item and is often used in conjunction with other tests in clinical settings to assess individuals with DE. Created in 1997, the original OSDI consisted of 12 items and was designed to evaluate subjective dry eye symptoms and the consequences of DED on vision-related activities of daily life over the preceding week. The 12 items are grouped into three subscales: ocular symptoms (three items), vision-related functions (six items), and environmental triggers (three items). While the original version of the OSDI-12 questionnaire was created in English and was later translated and validated into other languages, it should be used carefully since the cutoff values vary among various languages (27.2 points for the Chinese version and 36.3 points for the Japanese version) . Recent research using Rasch analysis found that separating answer items into four categories by merging "half of the time" and "most of the time" might lead to higher thresholds and better intervals in each category. The OSDI-12 total score is calculated using the formula: [(sum of scores for all questions answered) × 100]/ [(total number of questions answered) × 4]. Ocular Surface Disease Index-6 (OSDI-6) is a derivative and shortened version of the original OSDI-12 and can potentially improve efficiency in a busy clinical setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Dry eye patients were recruited to fill in the questionnaire |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with dry eye
Key inclusion criteria (3 listed)
- Diagnosed dry eye
- Able and willing to comply with the schedule
- Able to read and understand the C-OSDI-12 questionnaire independently
Key exclusion criteria (1 listed)
- The researchers judged to be not suitable
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
OSDI12
Time frame: Baseline
The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome
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 20 Feb 2024.
- Background: PubMed 28736343Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20.
- Background: PubMed 28736335Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
- Background: PubMed 10815152Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
- Background: PubMed 12131034Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.
- Background: PubMed 30225139Lu F, Tao A, Hu Y, Tao W, Lu P. Evaluation of Reliability and Validity of Three Common Dry Eye Questionnaires in Chinese. J Ophthalmol. 2018 Aug 27;2018:2401213. doi: 10.1155/2018/2401213. eCollection 2018.
- Background: PubMed 31772113Midorikawa-Inomata A, Inomata T, Nojiri S, Nakamura M, Iwagami M, Fujimoto K, Okumura Y, Iwata N, Eguchi A, Hasegawa H, Kinouchi H, Murakami A, Kobayashi H. Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease. BMJ Open. 2019 Nov 25;9(11):e033940. doi: 10.1136/bmjopen-2019-033940.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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?
An observational study of Dry Eye, run by He Eye 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 20 Feb 2024. 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?
OSDI12 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158906, which also lists 6 linked publications.
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 20 Feb 2024.