Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery

Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery

To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: heads-up method

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Eye Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnose age-related cataract;
2. Plan to perform phacoemulsification of cataract with intraocular lens implantation;
3. Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
4. Able to understand and independently fill in the informed consent form and postoperative follow-up plan.

Exclusion Criteria:

1. Cataract caused by other reasons;
2. Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
3. Corneal diseases, corneal endothelial cells <1800/mm2;
4. Small palpebral fissure;
5. Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
6. Those who cannot cooperate with the inspection and have not completed the one-month follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cataract surgery performed by heads-up method; 3D heads-up surgery was performed under the NGENUITY® 3D visualization system	Procedure: heads-up method; 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.
No Intervention: Traditional surgery; Traditional surgery was performed under a surgical microscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 1day,1week,1 month
corneal endothelial cell density	the number of corneal endothelial cells per unit area	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best corrected visual acuity	best corrected visual acuity	up to 1 month
change from baseline central corneal thickness at 1 months	thickness in micrometer	up to 1 day,1 week,1 month
change from baseline corneal incision thickness at 1 months	Thickness of corneal incision	up to 1 day,1 week,1 month

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: phacoemulsification; microsurgery; three-dimensional surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 3D system-CPJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No