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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ripasudil
DrugGlanatec Ophthalmic Solution 0.4% W/V with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma. Inhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil.
Placebo
Other interventionSaline eye drops
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope. This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Time frame
3 monthsSecondary outcomes
1
To monitor for conjunctival hyperemia in participants in treatment group.
The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia. The investigators will grade the conjunctival hyperemia This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov