| Eligibility |
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 LogMAR 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. Subjects with intraocular lens (IOL) implant in either eye
4. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the
planned study period
5. Subject with shallow anterior chamber
6. Subject who have had a fluorescence angiogram or any use of fluorescein within the
last 3 days
7. Subject presenting eye infection or eye damage in either eye
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. Subject participated in the previous study with the LEDINBIO CE Device (EB-14-LAT)
13. Females who are pregnant or lactating
14. 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.
|
