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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839250
• Other study ID #: 3D system-CPJ
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: May 2022
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	corneal endothelial cell density	the number of corneal endothelial cells per unit area	up to 1 month
Secondary	best corrected visual acuity	best corrected visual acuity	up to 1 month
Secondary	change from baseline central corneal thickness at 1 months	thickness in micrometer	up to 1 day,1 week,1 month
Secondary	change from baseline corneal incision thickness at 1 months	Thickness of corneal incision	up to 1 day,1 week,1 month