Back to resultsDifference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
heads-up method
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring three-dimensional surgery, microsurgery, phacoemulsification
Eligibility Criteria
Inclusion Criteria:
- Diagnose age-related cataract;
- Plan to perform phacoemulsification of cataract with intraocular lens implantation;
- Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
- Able to understand and independently fill in the informed consent form and postoperative follow-up plan.
Exclusion Criteria:
- Cataract caused by other reasons;
- Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
- Corneal diseases, corneal endothelial cells <1800/mm2;
- Small palpebral fissure;
- Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
- Those who cannot cooperate with the inspection and have not completed the one-month follow-up
Sites / Locations
- Eye Hospital of Wenzhou Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cataract surgery performed by heads-up method
Traditional surgery
Arm Description
3D heads-up surgery was performed under the NGENUITY® 3D visualization system
Traditional surgery was performed under a surgical microscope.
Outcomes
Primary Outcome Measures
change of corneal incision from 1day after surgery to 1 months
the shape and length of the corneal incision ，if descemet's layer detachment happens
corneal endothelial cell density
the number of corneal endothelial cells per unit area
Secondary Outcome Measures
best corrected visual acuity
best corrected visual acuity
change from baseline central corneal thickness at 1 months
thickness in micrometer
change from baseline corneal incision thickness at 1 months
Thickness of corneal incision
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04839250
Brief Title
Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Official Title
Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery
Detailed Description
To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
three-dimensional surgery, microsurgery, phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cataract surgery performed by heads-up method
Arm Type
Experimental
Arm Description
3D heads-up surgery was performed under the NGENUITY® 3D visualization system
Arm Title
Traditional surgery
Arm Type
No Intervention
Arm Description
Traditional surgery was performed under a surgical microscope.
Intervention Type
Procedure
Intervention Name(s)
heads-up method
Intervention Description
3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.
Primary Outcome Measure Information:
Title
change of corneal incision from 1day after surgery to 1 months
Description
the shape and length of the corneal incision ，if descemet's layer detachment happens
Time Frame
up to 1day,1week,1 month
Title
corneal endothelial cell density
Description
the number of corneal endothelial cells per unit area
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
best corrected visual acuity
Description
best corrected visual acuity
Time Frame
up to 1 month
Title
change from baseline central corneal thickness at 1 months
Description
thickness in micrometer
Time Frame
up to 1 day,1 week,1 month
Title
change from baseline corneal incision thickness at 1 months
Description
Thickness of corneal incision
Time Frame
up to 1 day,1 week,1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnose age-related cataract;
Plan to perform phacoemulsification of cataract with intraocular lens implantation;
Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
Able to understand and independently fill in the informed consent form and postoperative follow-up plan.
Exclusion Criteria:
Cataract caused by other reasons;
Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
Corneal diseases, corneal endothelial cells <1800/mm2;
Small palpebral fissure;
Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
Those who cannot cooperate with the inspection and have not completed the one-month follow-up
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35749016
Citation
Zhu Z, Chang P, Huang F, Shen S, Zhao X, Ji X, Zhao YE. Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1589-1600. doi: 10.1007/s40123-022-00537-4. Epub 2022 Jun 24.
Results Reference
derived
Learn more about this trial
Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
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