The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-100
SponsorSingapore Eye Research Institute
About this trial
The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.
Eligibility criteria
Qualifiers
Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens that interferes with normal vision).
Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.
Disqualifiers
Patients who are unable to give consent.
An only-functioning eye in a patient who has lost visual potential in the contralateral eye.
Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.
History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.
Trial design
Treatments tested in this trial
- Ripasudil
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov