Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Endothelial cell count (ECC)
Study Overview
Brief Summary
Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.
Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale [10]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
Exclusion Criteria
- •Endothelial cell count less than 1900,
- •glaucoma,
- •IOP-lowering medications,
- •former incisional surgery,
- •former diagnosis of corneal disease,
- •diabetes or autoimmune diseases
Outcomes
Primary Outcomes
Endothelial cell count (ECC)
Time Frame: 1 month postoperatively
Secondary Outcomes
- Uncorrected visual acuity (UVA)(1 month postoperatively)
- Central corneal thickness (CCT)(1 month postoperatively)
- Central Corneal Sensitivity (CCS)(1 month postoperatively)
Investigators
Georgios Labiris
Senior Lecturer
Democritus University of Thrace