Clinical trial NCT04839250: Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Official title: Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: three-dimensional surgery
microsurgery
phacoemulsification
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change of corneal incision from 1day after surgery to 1 months
timeFrame: up to 1day,1week,1 month
measure: corneal endothelial cell density
timeFrame: up to 1 month
Secondary outcomes:
measure: best corrected visual acuity
timeFrame: up to 1 month
measure: change from baseline central corneal thickness at 1 months
timeFrame: up to 1 day,1 week,1 month
measure: change from baseline corneal incision thickness at 1 months
timeFrame: up to 1 day,1 week,1 month
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
citation: 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.