Questionnaire Clinical Trial
— CLDEQ-8Official title:
Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) Among Chinese Soft Contact Lens Wearers
Verified date | November 2023 |
Source | Zhongshan Ophthalmic Center, Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a cross-cultural adaptation, evaluation and validation study of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among soft contact lens wearers in China.
Status | Completed |
Enrollment | 134 |
Est. completion date | April 22, 2023 |
Est. primary completion date | November 18, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Age between 18-60 2. Native Chinese citizens with Chinese as first language 3. Wearing history with spherical disposable SCL (daily disposable, 2 weeks, or monthly disposable) for a least 1 months; 4. Willing to sign informed consent Exclusion Criteria: 1. Any extended wear of SCLs, including wearing toric or multi-focal SCLs 2. Use SCL for monovision correction 3. Having clinically significant anterior segment abnormalities (including iritis and infection of the eye, lids, or ocular adnexa) 4. Having ocular or systemic disease that would preclude SCL wearing 5. Best corrected visual acuity of less than 0.8 in either eye 6. History of refractive or other types of corneal surgeries 7. Having eyelid abnormalities or functional ocular disorders that would induce relevant discomfort. 8) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhongshan Ophthalmic Center, Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The reliability of the C-CLDEQ-8 | Subjects are asked to complete C-CLDEQ-8. Internal consistency (reliability) of the C-CLDEQ-8 is evaluated using the Cronbach's Alpha analysis and the corrected index of homogeneity. For Cronbach´s Alpha results: < 0.5 is considered unacceptable; 0.5-0.6 poor; 0.6-0.7 questionable; 0.7-0.8 acceptable; 0.8-0.9 good; and > 0.9 excellent. | before the ocular examination | |
Secondary | The repeatability of the C-CLDEQ-8 | a subgroup of 50 participants are asked to complete C-CLDEQ-8 twice. Intraclasss correlation coefficient between the two scores of the first and second questionnaire evaluation is used to evaluate the repeatability. >0.7 is considered reliable. | before and after the ocular examination on the same day of visit | |
Secondary | Cutoff score for C-CLDEQ-8 to predict "Excellent/Very Good" overall of SCLs. | The Youden-index method is used to determine the cutoff value of the C-CLDEQ-8 score that maximized sensitivity+specificity -1. | before the ocular examination |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05514587 -
Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
|
||
Recruiting |
NCT06247852 -
Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
|
||
Recruiting |
NCT06293001 -
Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the ADAP Shoulder Scale
|
||
Not yet recruiting |
NCT03477240 -
Feasibility Study Of A Telephonic Questionnaire For Follow-Up Of Locally Advanced Cervical Cancer Patients
|
||
Not yet recruiting |
NCT03074747 -
Comparison of Four Questionnaires for OSA Screening in China
|
N/A | |
Recruiting |
NCT03803878 -
Translation and Validation of MESA Questionnaire of Chinese Language Version
|
||
Recruiting |
NCT04491201 -
National Survey of the Impact of COVID-19 Pandemics
|
||
Recruiting |
NCT04492085 -
National Survey of Workplace Violence
|
||
Recruiting |
NCT06266273 -
Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale
|
N/A | |
Completed |
NCT04406025 -
Regional Anesthesia Practice in Greece
|
||
Recruiting |
NCT05213416 -
BETY-BIOPSYCHOSOCIAL QUESTIONNAIRE IN PARTİCİPANTS RECEIVING RADIOTHERAPY
|
||
Completed |
NCT01277588 -
Evaluation of the Physicians and Patients Experience of Fetal Scalp Sampling
|
N/A | |
Completed |
NCT03164824 -
Thai Version of Functional Rating Index
|
N/A | |
Active, not recruiting |
NCT05903300 -
Validation of the Polish Version of the MPIIQM Questionnaire for Musicians
|
||
Recruiting |
NCT04785040 -
The Turkish Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-T)
|
||
Recruiting |
NCT06075186 -
Secondary Victim Awareness of Anesthesiologists
|