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Completed

NCT Number: NCT06636279

A Randomized Study of Gas Bubble Technique in Cataract Surgery

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

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Key information

Conditions

Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 646000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gas bubble technique

Procedure

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

Primary outcomes

  1. Endothelial cell loss (ECL)

    Time frame: 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 outcomes

  1. Central corneal thickness (CCT) increase rates

    Time frame: 1 week and 1 month

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

  2. Coefficient of variation (CV)

    Time frame: 1 week and 1 month

    Coefficient of variation reflected polymegathism

  3. hexagonality (HEX)

    Time frame: 1 week and 1 month

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

Other outcomes

  1. Intraocular pressure

    Time frame: 1day, 1week, 1 month

    Intraocular pressure measurement

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Clinical Effects of "Gas Bubble Technique" on Corneal Endothelial Recovery After Cataract Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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