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

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

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Procedure: heads-up method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cataract surgery performed by heads-up method<br>3D heads-up surgery was performed under the NGENUITY® 3D visualization system | Procedure: heads-up method<br>* 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.<br>|
| No Intervention: Traditional surgery<br>Traditional surgery was performed under a surgical microscope. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity | best corrected visual acuity | up to 1 month | 
| change from baseline central corneal thickness at 1 months | thickness in micrometer | up to 1 day,1 week,1 month | 
| change from baseline corneal incision thickness at 1 months | Thickness of corneal incision | up to 1 day,1 week,1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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three-dimensional surgery, microsurgery, phacoemulsification