A Randomized Study of Gas Bubble Technique in Cataract Surgery

December 11, 2025 updated by: Rui Feng, PhD, Sichuan Provincial People's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 646000
        • Sichuan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gas bubble group
Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce the corneal endothelial damage
Procedure: Gas bubble technique
Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce corneal endothelial damage
No Intervention: The control group
Conventional cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central corneal thickness (CCT) increase rates
Time Frame: 1 week and 1 month
CCT increase rates = ([postoperative CCT - preoperative CCT]/preoperative CCT) × 100%
1 week and 1 month
Coefficient of variation (CV)
Time Frame: 1 week and 1 month
Coefficient of variation reflected polymegathism
1 week and 1 month
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
1 week and 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: 1day, 1week, 1 month
Intraocular pressure measurement
1day, 1week, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

February 10, 2025

Study Completion (Actual)

March 8, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SichuanPPH2024331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the article is published, the data can be obtained from the corresponding author upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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