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

Wenzhou Medical University

Status: Completed

Conditions: Cataract

Treatments: Procedure: heads-up method

Study type: Interventional

Funder types: Other

Identifiers

NCT04839250

3D system-CPJ

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

cataract surgery performed by heads-up method

Experimental group

Description:

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

Treatment:

Procedure: heads-up method

Traditional surgery

No Intervention group

Description:

Traditional surgery was performed under a surgical microscope.