Comparison of Wound Integrity for Clear Corneal Cataract Incisions
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pressure by a cotton swab
stromal hydration with the balanced salt solution(BSS)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- > 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongshan Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cotton swab
balanced salt solution (BSS)
Arm Description
Outcomes
Primary Outcome Measures
Degree of incision closure
Degree of incision closure is evaluated by intraoperative optical coherence tomography.
Secondary Outcome Measures
Rate of wound leakage
Rate of wound leakage is evaluated by fluorescein sodium.
Corneal thickness
Corneal thickness is measured by Casia 2.
Corneal curvature
Corneal curvature is measured by Casia 2.
Anterior chamber depth
Anterior chamber depth is measured by Casia 2.
Rate of incision-related descemet membrane detachment during surgery
Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.
Rate of incision-related descemet membrane detachment after surgery
Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.
Full Information
NCT ID
NCT05242653
First Posted
January 24, 2022
Last Updated
September 8, 2022
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05242653
Brief Title
Comparison of Wound Integrity for Clear Corneal Cataract Incisions
Official Title
Comparison of Wound Integrity for Clear Corneal Cataract Incisions: Pressure Versus Stromal Hydration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cotton swab
Arm Type
Experimental
Arm Title
balanced salt solution (BSS)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
pressure by a cotton swab
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
stromal hydration with the balanced salt solution(BSS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of incision closure
Description
Degree of incision closure is evaluated by intraoperative optical coherence tomography.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Rate of wound leakage
Description
Rate of wound leakage is evaluated by fluorescein sodium.
Time Frame
During surgery
Title
Corneal thickness
Description
Corneal thickness is measured by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
Title
Corneal curvature
Description
Corneal curvature is measured by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
Title
Anterior chamber depth
Description
Anterior chamber depth is measured by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
Title
Rate of incision-related descemet membrane detachment during surgery
Description
Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.
Time Frame
During surgery
Title
Rate of incision-related descemet membrane detachment after surgery
Description
Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Wound Integrity for Clear Corneal Cataract Incisions
We'll reach out to this number within 24 hrs