Clinical trial: NCT05170347
Section: Confidentiality
Subsections: Confidentiality

The research team will have access to your medical records. Electronic data will be only saved in physically-secured and password-protected computers in our research office. All the information collected is for research purposes only and will be kept strictly confidential. None of your information will not be disclosed to any third party without your consent. We will keep your information (including your medical record information) confidential to the extent permitted by laws and/or regulations, and will not make it public. If the research team needs to publish or submit the study results in scientific meetings or journals, your name and identifying information will not be disclosed. If necessary, each participant has their right to acquire their personal data and the publicly reported results. Records and results of all study investigations can be destroyed on your request in future. By signing a written informed consent form, you are authorizing the Research Ethics Committee (REC) and the regulatory authority(ies) a direct access to your original research records for verification of clinical trial procedures and/or data, without violating your confidentiality, to the extent permitted by the applicable laws and regulations. Personal data will be kept for 5 years after study completion. Under the laws of Hong Kong (in particular the Personal Data (Privacy) Ordinance, Cap 486), you enjoy or may enjoy rights for the protection of the confidentiality of your personal data, such as those regarding the collection, custody, retention, management, control, use (including analysis or comparison), transfer in or out of Hong Kong, non-disclosure, erasure and/or in any way dealing with or disposing of any of your personal data in or for this study. For any query, you should consult the Privacy Commissioner for Personal Data or their officer (Tel no.: 2827 2827) as to the proper monitoring or supervision of your personal data protection so that your full awareness and understanding of the significance of compliance with the law governing privacy data is assured.
Clinical trial: NCT05170347
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Potential Benefits|Potential Risks Or Discomfort

Participants will be closely monitored for any emerging sign of oGVHD. Participants could seek medical attention in no time if any clinical manifestation of oGVHD started to appear. Participants will help the society by contributing to the medical research of oGVHD.

Participating in this study will not increase potential risks. Conjunctival swab and tear collection may cause very mild discomfort. These sample collection methods are widely used worldwide and in general very well tolerated. Costs and rewards **of the study** Participants will not be charged an extra fee for participating in this study. Alternative treatments if participant opts out of **the study**
The participant will continue to receive routine care if they opt not to join the study.  
Expected research period You will be in the study for up to about 5 years. Circumstances under which your participation in the research will be terminated We reserve the right to terminate your participation in the research project. If any safety concerns are raised during the study, interim results from the study showed no additional samples are needed, or you are not available to attend follow-up visits, you will be informed your participation will no longer be required.
Clinical trial: NCT05170347
Section: Procedures
Subsections: Description Of Study Design And Procedures

This is a prospective observational study. Patients will be invited for assessment at baseline within one month prior to HSCT, and at months 3, 6, 9, 12 after HSCT, with an optional extension to 18 and 24 months, and annually up to 5 years. During each visit, a comprehensive eye examination will be performed by an ophthalmologist experienced in oGVHD. Symptom questionnaires, tear film parameters, imaging of the ocular surface and anterior segment will also be carried out. Tear and conjunctival swab samples will be collected in some visits. One accompanying family member of the patients will also be recruited as the family control. Family control subjects will receive eye assessments performed by an ophthalmologist. Microbiome and tear samples will be collected for comparison. The schedule of assessment and collection is the same as the corresponding post-HSCT case.
Clinical trial: NCT05170347
Section: Voluntary Participation
Subsections: Voluntary Participation / Withdrawal /

Your participation in this study is entirely voluntary. You will be updated of new information that may be relevant to your willingness to continue participation in the study. You are allowed as much time as you need to consider participation in this study, or to discuss with your relatives prior to signing the informed consent form. You can call us via the contact telephone number provided on this participant information sheet when you need help making your decision. You have the right to refuse participation or to withdraw from this study at any time, with no prejudice towards your present or future medical treatments at the Chinese University of Hong Kong or any of the hospitals involved. After signing the Informed Consent Form, a Participant Information Sheet and a copy of signed Informed Consent Form will be given. Even after signing the informed consent form, you are free to withdraw your consent and discontinue your participation in the study at any time. Once you request to withdraw, all clinical data arising from study investigations will be deleted. The clinical data in the medical records will, however, be retained for future clinical management.