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A Randomized Study of Gas Bubble Technique in Cataract Surgery

NCT ID: NCT06636279

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-03-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Gas bubble group

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

Group Type EXPERIMENTAL

Gas bubble technique

Intervention Type PROCEDURE

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

The control group

Conventional cataract surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gas bubble technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rui Feng, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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SichuanPPH2024331

Identifier Type: -

Identifier Source: org_study_id