Corneal Endothelial Damage Following the Hard Nuclear Cataract SurgeryNCT06636279
A Randomized Study of Gas Bubble Technique in Cataract Surgery
A study testing Gas bubble technique in people with Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
To investigate the efficiency and safety of using "Gas Bubble Technique" to reduce corneal endothelial damage in hard nucleus cataract patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
- What is being tested?
- Gas bubble technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 8 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any ocular surgery history
- Currently diagnosis of severe ocular disease and under medication
- Uncontrolled systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Gas bubble technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gas bubble techniqueProcedure or surgery
Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce corneal endothelial damage
| Study group | Role | What they receive |
|---|---|---|
| Gas bubble group | Experimental | Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce the corneal endothelial damage Receives: Procedure: Gas bubble technique |
| The control group | No intervention | Conventional cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week and 1 month
Secondary outcomes (3)
Central corneal thickness (CCT) increase rates
CCT increase rates = ([postoperative CCT - preoperative CCT]/preoperative CCT) × 100%
Measured: 1 week and 1 month
Coefficient of variation (CV)
Coefficient of variation reflected polymegathism
Measured: 1 week and 1 month
hexagonality (HEX)
The percentage of hexagonality represented pleomorphism, indicating the ratio of hexagonal cells to cells of other shapes
Measured: 1 week and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2024
- Primary completion10 Feb 2025
- Study completion8 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal Endothelial Damage Following the Hard Nuclear Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Feng, PhD, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636279
- Sponsor's protocol ID
- SichuanPPH2024331
- Status last verified
- Apr 2025
- First submitted
- 8 Oct 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the article is published, the data can be obtained from the corresponding author upon reasonable request
Publications
Feng R, Peng R, Chen S, Wang B, Li A, Luo Y, Zhang C, Yu H, Qu C. Effect of Intracameral Air Injection on Corneal Endothelial Cell Loss After Phacoemulsification for Cataracts of LOCS III Nuclear Grade 4 or Higher: A Randomised Clinical Trial. Clin Exp Ophthalmol. 2026 Sep 14. doi: 10.1111/ceo.70161. Online ahead of print.
PubMed 42734093
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of "Gas Bubble Technique" on Corneal Endothelial Recovery After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06636279
- Acronym / sponsor ID
- SichuanPPH2024331
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficiency and safety of using "Gas Bubble Technique" to reduce corneal endothelial damage in hard nucleus cataract patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gas bubble group | Experimental | Procedure: Gas bubble techniqueInject the sterile air into the anterior chamber after the conventional cataract surgery to reduce the corneal endothelial damage |
| The control group | No intervention | –Conventional cataract surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Any ocular surgery history
- Currently diagnosis of severe ocular disease and under medication
- Uncontrolled systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gas bubble techniqueInject the sterile air into the anterior chamber after the conventional cataract surgery to reduce corneal endothelial damage | Procedure or surgery | Gas bubble group |
Primary outcome
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.
3 secondary outcomes
Central corneal thickness (CCT) increase rates
Time frame: 1 week and 1 month
Coefficient of variation (CV)
Time frame: 1 week and 1 month
hexagonality (HEX)
Time frame: 1 week and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42734093Feng R, Peng R, Chen S, Wang B, Li A, Luo Y, Zhang C, Yu H, Qu C. Effect of Intracameral Air Injection on Corneal Endothelial Cell Loss After Phacoemulsification for Cataracts of LOCS III Nuclear Grade 4 or Higher: A Randomised Clinical Trial. Clin Exp Ophthalmol. 2026 Sep 14. doi: 10.1111/ceo.70161. Online ahead of print.
- Individual participant dataSharing planned: Yes. After the article is published, the data can be obtained from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gas bubble technique in people with Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell loss (ECL) (time frame: 1 week and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06636279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.