Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT04569318
Eligibility Criteria:
Inclusion Criteria:
1. Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator
2. Subject aged between 55 and 85 years of age (inclusive) at the time of consent
3. Best corrected visual acuity (BCVA) of 0.3 or worse due to cataract only
4. Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study
5. Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator
6. Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator - including being able to sit upright for at least 20 mins (duration of the treatment)
Exclusion Criteria:
1. Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalised by court or official order, or in a dependency relationship with sponsor, testing centre or investigator
2. Subject who had been clinically diagnosed with any eye diseases which may impact upon the treatment, or the subject's ability to be assessed after treatment
3. Subject with shallow anterior chamber
4. Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days
5. Subject presenting eye infection or eye damage in either eye
6. Subject routinely using contact lenses
7. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
8. Any condition which could interfere with the subject's ability to comply with the study including participation in all study assessments and visits.
9. Subject who had undergone a treatment using photodynamic drugs within the last 30 days. (Including but not limited to methylene blue, toluidine blue, Visudyne®, Foscan, Photofrin or 5-aminolevulinic acid/ALA)
10. Subject diagnosed with any other health condition which, in the opinion of the Investigator, would pose a safety risk to the subject by participating in the study, or may interfere with or jeopardise the study evaluation, procedures or completion
11. Subject currently receiving treatment in another investigational study or has completed another investigational study within the last 30 days
12. Females who are pregnant or lactating
13. Females who are of childbearing potential (menses within the last 12 months) and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable contraceptive precautions may be included.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT04569318
Study Brief:
Protocol Section:
NCT04569318