Cataract
Conditions
Keywords
three-dimensional surgery, microsurgery, phacoemulsification
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.
Interventions
PROCEDUREheads-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.
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of corneal incision from 1day after surgery to 1 months | up to 1day,1week,1 month | the shape and length of the corneal incision ，if descemet's layer detachment happens |
| corneal endothelial cell density | up to 1 month | the number of corneal endothelial cells per unit area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| best corrected visual acuity | up to 1 month | best corrected visual acuity |
| change from baseline central corneal thickness at 1 months | up to 1 day,1 week,1 month | thickness in micrometer |
| change from baseline corneal incision thickness at 1 months | up to 1 day,1 week,1 month | Thickness of corneal incision |
Countries
China
Outcome results
None listed