Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- Endothelial cell density (ECD)
Study Overview
Brief Summary
Purpose: The aim of this study was to evaluate corneal endothelial cell density and morphology, central corneal thickness, and best visual acuity using US phacoemulsification or Nanosecond laser technique.
Setting: Department of ophthalmology, Nabeul, Tunisia. Design: Prospective cohort study. Methods: The study included eyes with nuclear cataract density grade 1, 2, 3, or 4 according to LOCS III, divided into two groups; Group 1 had conventional US, and group 2 had nanosecond laser. The Endothelial Cell Density (ECD), coefficient of variation (CoV) in cell size, percentage of hexagonal cells, central corneal thickness and best visual acuity were evaluated over 24 months.
Detailed Description
Methods:
A randomized prospective, uncontrolled cohort study was conducted at the Department of Ophthalmology of the Mohamed Taher Maamouri Hospital (MTMH) from March 2017 to May 2020. The MTMH ethics committee approved this study. All patients provided informed consent for the use of their data. The study adhered to all tenets of the declaration of Helsinki.
All patients underwent complete ocular examination including visual acuity, clinical corneal assessment, intraocular pressure (IOP) measurement, and nuclear hardness grading based on the lens opacity classification system III (LOCS III), commonly referred to in most studies. Only the nuclear component of the cataract (NO1 to NO4) was taken into account in the evaluation.
The endothelium of the central cornea was examined with a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Patients were randomly divided into 2 groups. Group 1 had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®) and group 2 underwent an NL PHACO (Cetus A.R.C. Laser system®).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
the investigator does not know the technique used to operate on the cataract during the follow-up
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Senile cataract.
- •Non Inclusion Criteria:
- •Preoperative endothelial cell count (ECC) less than 1500 cells/mm
- •Pathological alterations of the anterior segment such as corneal opacities, cornea Guttata, uveitis, pseudoexfoliative syndrome, glaucoma, high myopia axil length (≥ 26 mm), or suffering from chronic pathologies that may affect corneal endothelium
Exclusion Criteria
- •Conversion from NL PHACO to US PHACO.
- •Surgery was complicated with capsular rent and vitreous loss.
Outcomes
Primary Outcomes
Endothelial cell density (ECD)
Time Frame: 2 years
The endothelium of the central cornea was examined using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Percentage of endothelial cell loss (ECL)
Time Frame: 2 years
ECL was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Mean percentage of hexagonal cells
Time Frame: 2 years
The mean percentage of hexagonal cells was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Mean coefficient of variance (CoV)
Time Frame: 2 years
CoV was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Central corneal thickness (CCT)
Time Frame: 2 years
CCT was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Best corrected visual acuity (BCVA)
Time Frame: 2 years
Uncorrected visual acuity (UVA)
Time Frame: 2 years
UVA was evaluated at 1 day post-operatively
Secondary Outcomes
No secondary outcomes reported
Investigators
Walid Zbiba
professor
University Tunis El Manar