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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: heads-up method

• Registration Number: NCT04839250
• Lead Sponsor: Wenzhou Medical University

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cataract surgery performed by heads-up method	heads-up method	3D heads-up surgery was performed under the NGENUITY® 3D visualization system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Eye Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China