A Randomized Study of Gas Bubble Technique in Cataract Surgery

Sichuan Provincial People's Hospital80 enrolled

Overview

To investigate the efficiency and safety of using "Gas Bubble Technique" to reduce corneal endothelial damage in hard nucleus cataract patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery

Interventions

Gas bubble techniquePROCEDURE

Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce corneal endothelial damage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Endothelial cell loss (ECL)

The endothelial cell loss (ECL) was calculated as the percentage change in ECD from preoperative to postoperative values relative to the preoperative ECD.

Time frame: 1 week and 1 month

Secondary Outcomes

Central corneal thickness (CCT) increase rates

CCT increase rates = (\[postoperative CCT - preoperative CCT\]/preoperative CCT) × 100%

Time frame: 1 week and 1 month

Coefficient of variation (CV)

Coefficient of variation reflected polymegathism

Time frame: 1 week and 1 month

hexagonality (HEX)

The percentage of hexagonality represented pleomorphism, indicating the ratio of hexagonal cells to cells of other shapes

Time frame: 1 week and 1 month

Data from ClinicalTrials.gov

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