A Randomized Study of Gas Bubble Technique in Cataract Surgery

NCT06636279 | Completed DMC

• 1 other identifier: SichuanPPH2024331
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week and 1 month

Secondary Outcomes (3)

• Central corneal thickness (CCT) increase rates

  1 week and 1 month

• Coefficient of variation (CV)

  1 week and 1 month

• hexagonality (HEX)

  1 week and 1 month

Other Outcomes (1)

• Intraocular pressure

  1day, 1week, 1 month

Study Arms (2)

Gas bubble group

EXPERIMENTAL

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

Procedure: Gas bubble technique

The control group

NO INTERVENTION

Conventional cataract surgery

Interventions

Gas bubble technique PROCEDURE

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

Gas bubble group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent approved by the Ethics Committee
• 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

You may not qualify if:

• Any ocular surgery history
• Currently diagnosis of severe ocular disease and under medication
• Uncontrolled systemic diseases

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 646000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 10, 2024
• Primary Completion: February 10, 2025
• Study Completion: March 8, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)