Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
Conditions
Brief summary
To investigate the efficiency and safety of using Gas Bubble Technique to reduce corneal endothelial damage in hard nucleus cataract patients.
Detailed description
The study is designed to: test the hypothesis that the Gas Bubble Technique is an effective method for reducing corneal endothelial damage. Describe and evaluate the effects of Gas Bubble Technique on a well-defined group of patients over a 1-month period following treatment.
Interventions
PROCEDUREGas bubble technique
Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce corneal endothelial damage
Sponsors
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Sign the informed consent approved by the Ethics Committee * 18-80 years of age * Catract patients with hard nucleus (LOSIII N Score ≥4) who are scheduled for phacoemulsification * Feasible for all visits and willing to follow instructions from the study investigator
Exclusion criteria
* Any ocular surgery history * Currently diagnosis of severe ocular disease and under medication * Uncontrolled systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell loss (ECL) | 1 week and 1 month | The endothelial cell loss (ECL) was calculated as the percentage change in ECD from preoperative to postoperative values relative to the preoperative ECD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central corneal thickness (CCT) increase rates | 1 week and 1 month | CCT increase rates = (\[postoperative CCT - preoperative CCT\]/preoperative CCT) × 100% |
| Coefficient of variation (CV) | 1 week and 1 month | Coefficient of variation reflected polymegathism |
| hexagonality (HEX) | 1 week and 1 month | The percentage of hexagonality represented pleomorphism, indicating the ratio of hexagonal cells to cells of other shapes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 1day, 1week, 1 month | Intraocular pressure measurement |
Countries
China
Outcome results
None listed