CataractNCT05242653
Comparison of Wound Integrity for Clear Corneal Cataract Incisions
A study testing pressure by a cotton swab and stromal hydration with the balanced salt solution（BSS） in people with Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- pressure by a cotton swab and stromal hydration with the balanced salt solution（BSS）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2022to 8 Sep 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old;
- Nuclear grade is III or IV;
- Visually significant cataract;
- The patient is willing and able to complete all necessary follow-ups and examinations.
Who cannot join
- Intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.;
- Combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
- History of intraocular surgery;
- Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
- Any condition that the study physician considers to be an impediment to the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Wound Integrity for Clear Corneal Cataract Incisions: Pressure Versus Stromal Hydration
This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions
Read the detailed description
Compared with other incision types , clear corneal incision has the advantages of simple operation, small incision and good healing. It has been widely used in recent decades and has become the most commonly used incision type in phacoemulsification cataract surgery.However, there is no unified standard for the closed method of the clear corneal incision, and some studies have shown that the wound Integrity of clear corneal incision is not well.In the poorly closed incision, the risk of infection increased due to the leakage .Especially in 2.2mm incision, the frequent entry and exit of the instrument reduces the corneal rebound ability at the incision so that the incision is hard to closed. Ensuring wound Integrity for clear corneal cataract incision is the key to the success of cataract surgery.
Clinically closed methods include stromal hydration and suture.The effectiveness of stromal hydration as one of the most commonly used methods has been validated, but also adds additional negative effects. Additionally, the suture extends the operation time and improves the operation cost, and is also accompanied by some complications, which has been less used. Exploring a safe and effective closed method will benefit for most cataract patients.
This study intends to evaluate the safety and efficacy of a closed method that incision is pressed by a cotton swab.The investigators planned to select 130 cataract patients who met the inclusion criteria. The investigators will press the clear corneal incision with a cotton swab in experimental group, while the control group used stromal hydration to close the corneal incision. Wound Integrity, wound leakage, corneal thickness at the incision, keratometric value at the incision, anterior chamber depth and incidence of incision-related descemet membrane detachment were compared between the two groups.
- Conditions
- Cataract
- Being tested
- pressure by a cotton swab, stromal hydration with the balanced salt solution（BSS）
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure by a cotton swabProcedure or surgery
All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with pressure by a cotton swab.
stromal hydration with the balanced salt solution（BSS）Procedure or surgery
All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with stromal hydration.
| Study group | Role | What they receive |
|---|---|---|
| cotton swab | Experimental | Not described Receives: Procedure: pressure by a cotton swab |
| balanced salt solution (BSS) | Active comparator | Not described Receives: Procedure: stromal hydration with the balanced salt solution（BSS） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of incision closure
Degree of incision closure is evaluated by intraoperative optical coherence tomography.
Measured: During surgery
Secondary outcomes (6)
Rate of wound leakage
Rate of wound leakage is evaluated by fluorescein sodium.
Measured: During surgery
Corneal thickness
Corneal thickness is measured by Casia 2.
Measured: 1 hour after surgery and 1 day after surgery
Corneal curvature
Corneal curvature is measured by Casia 2.
Measured: 1 hour after surgery and 1 day after surgery
Anterior chamber depth
Anterior chamber depth is measured by Casia 2.
Measured: 1 hour after surgery and 1 day after surgery
Rate of incision-related descemet membrane detachment during surgery
Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.
Measured: During surgery
Rate of incision-related descemet membrane detachment after surgery
Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.
Measured: 1 hour after surgery and 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start17 Feb 2022
- Primary completion30 Jun 2022
- Study completion8 Sep 2022
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 CataractStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242653
- Sponsor's protocol ID
- 2021KYPJ208
- Status last verified
- Sep 2022
- First submitted
- 24 Jan 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Z, Lin H, Jin L, Qu B, Liu J, Zheng Y, He M, Luo L, Liu Y. Swab Pressing vs Stromal Hydration to Prevent Incision Leakage and Transient Collapse of Anterior Chamber in Phacoemulsification: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.
PubMed 37166786
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wound Integrity for Clear Corneal Cataract Incisions: Pressure Versus Stromal Hydration
- ClinicalTrials.gov ID
- NCT05242653
- Acronym / sponsor ID
- 2021KYPJ208
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 16 Feb 2022 (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.
This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions
Detailed description
Compared with other incision types , clear corneal incision has the advantages of simple operation, small incision and good healing. It has been widely used in recent decades and has become the most commonly used incision type in phacoemulsification cataract surgery.However, there is no unified standard for the closed method of the clear corneal incision, and some studies have shown that the wound Integrity of clear corneal incision is not well.In the poorly closed incision, the risk of infection increased due to the leakage .Especially in 2.2mm incision, the frequent entry and exit of the instrument reduces the corneal rebound ability at the incision so that the incision is hard to closed. Ensuring wound Integrity for clear corneal cataract incision is the key to the success of cataract surgery.
Clinically closed methods include stromal hydration and suture.The effectiveness of stromal hydration as one of the most commonly used methods has been validated, but also adds additional negative effects. Additionally, the suture extends the operation time and improves the operation cost, and is also accompanied by some complications, which has been less used. Exploring a safe and effective closed method will benefit for most cataract patients.
This study intends to evaluate the safety and efficacy of a closed method that incision is pressed by a cotton swab.The investigators planned to select 130 cataract patients who met the inclusion criteria. The investigators will press the clear corneal incision with a cotton swab in experimental group, while the control group used stromal hydration to close the corneal incision. Wound Integrity, wound leakage, corneal thickness at the incision, keratometric value at the incision, anterior chamber depth and incidence of incision-related descemet membrane detachment were compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cotton swab | Experimental | Procedure: pressure by a cotton swab |
| balanced salt solution (BSS) | Active comparator | Procedure: stromal hydration with the balanced salt solution（BSS） |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old;
- Nuclear grade is III or IV;
- Visually significant cataract;
- The patient is willing and able to complete all necessary follow-ups and examinations.
Key exclusion criteria (5 listed)
- Intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.;
- Combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
- History of intraocular surgery;
- Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
- Any condition that the study physician considers to be an impediment to the clinical trial.
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 |
|---|---|---|
| pressure by a cotton swabAll patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with pressure by a cotton swab. | Procedure or surgery | cotton swab |
| stromal hydration with the balanced salt solution（BSS）All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with stromal hydration. | Procedure or surgery | balanced salt solution (BSS) |
Primary outcome
Degree of incision closure
Time frame: During surgery
Degree of incision closure is evaluated by intraoperative optical coherence tomography.
6 secondary outcomes
Rate of wound leakage
Time frame: During surgery
Corneal thickness
Time frame: 1 hour after surgery and 1 day after surgery
Corneal curvature
Time frame: 1 hour after surgery and 1 day after surgery
Anterior chamber depth
Time frame: 1 hour after surgery and 1 day after surgery
Rate of incision-related descemet membrane detachment during surgery
Time frame: During surgery
Rate of incision-related descemet membrane detachment after surgery
Time frame: 1 hour after surgery and 1 day after surgery
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 10 Sep 2022.
- Derived from this study: PubMed 37166786Liu Z, Lin H, Jin L, Qu B, Liu J, Zheng Y, He M, Luo L, Liu Y. Swab Pressing vs Stromal Hydration to Prevent Incision Leakage and Transient Collapse of Anterior Chamber in Phacoemulsification: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1;141(6):574-581. doi: 10.1001/jamaophthalmol.2023.1491.
- Individual participant dataSharing planned: Undecided
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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 pressure by a cotton swab and stromal hydration with the balanced salt solution（BSS） in people with Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 5 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 10 Sep 2022. 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?
Degree of incision closure (time frame: During surgery). 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 NCT05242653, 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 10 Sep 2022.