Endothelial cell and Central corneal thickness after Phacoemulsification surgery in Diabetic patients Rho-kinase inhibitor, Ripasudil, Endothelial cells, Cataract surgery, Diabetes
Conditions
Interventions
Treatment group receiving 0.4%ripasudil eye drops four times daily, starting on the first day after surgery and continuing for 1 month.,Placebo group receiving 0.1%Sodium hyaluronate artificial tears
Experimental Drug,Placebo Comparator Drug
Ripasudil,0.1%Sodium hyaluronate artificial tears
Sponsors
The Ratchadapisek Sompoch Fund, Faculty of Medicine, Chulalongkorn university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 18 years old 2. Cataract level 2 or higher according to the Lens Opacities Classification System III protocol 3. Diagnosed with diabetes type 2 according to the American Diabetes Association (ADA) criteria and HbA1c equal to or less than 8.5% within 3 months before operation 4. Underwent uncomplicated phacoemulsification surgery
Exclusion criteria
Exclusion criteria: 1. Unwilling to participate and sign the informed consent form 2. Currently receiving ongoing laser photocoagulation or intravitreal antiVEGF therapy 3. Lower preoperative ECD below 1000 cells per mm square 4. Macular edema 5. History of corneal transplantation or repair cornea or corneal ulcer or corneal dystrophy or perforated cornea 6. Shallow anterior chamber depth than 2.5 mm 7. Non adherent participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial cell density 3 months Specular microscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal densitometry 3 months Scheimpflug imaging in a Pentacam system,Central corneal thickness 3 months Specular microscopy | — |
Countries
Thailand
Contacts
Public ContactPATRARAMON CHOTIKKAKAMTHORN
Chulalongkorn University
Outcome results
None listed