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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04839250

Collaborator

(none)

Enrollment

Location

Arms

8.9

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: heads-up method	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

change of corneal incision from 1day after surgery to 1 months [up to 1day,1week,1 month]
the shape and length of the corneal incision ，if descemet's layer detachment happens
corneal endothelial cell density [up to 1 month]
the number of corneal endothelial cells per unit area

Secondary Outcome Measures

best corrected visual acuity [up to 1 month]
best corrected visual acuity
change from baseline central corneal thickness at 1 months [up to 1 day,1 week,1 month]
thickness in micrometer
change from baseline corneal incision thickness at 1 months [up to 1 day,1 week,1 month]
Thickness of corneal incision

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang	China

Sponsors and Collaborators

Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University, Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT04839250

Other Study ID Numbers:

3D system-CPJ

First Posted:

Apr 9, 2021

Last Update Posted:

May 12, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University, Wenzhou Medical University

three-dimensional surgery

microsurgery

phacoemulsification

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of May 12, 2022