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

NCT04839250 | Completed

• 1 other identifier: 3D system-CPJ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

three-dimensional surgery; microsurgery; phacoemulsification

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• best corrected visual acuity

  up to 1 month

• change from baseline central corneal thickness at 1 months

  up to 1 day,1 week,1 month

• change from baseline corneal incision thickness at 1 months

  up to 1 day,1 week,1 month

Study Arms (2)

cataract surgery performed by heads-up method

EXPERIMENTAL

3D heads-up surgery was performed under the NGENUITY® 3D visualization system

Procedure: heads-up method

Traditional surgery

NO INTERVENTION

Traditional surgery was performed under a surgical microscope.

Interventions

heads-up method PROCEDURE

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.

cataract surgery performed by heads-up method

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 35749016 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 9, 2021
• Study Start: February 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)