Cataract Clinical Trial
Official title:
Evaluation of Staged and Combined Phacoemulsification With Intraocular Lens (IOL) Implantation and Descemet Membrane Endothelial Keratoplasty (DMEK) for Cataract Patients With Corneal Endothelial Dysfunction
The purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and Descemet membrane endothelial keratoplasty (DMEK) to treat cataract patients with corneal endothelial dysfunction. Surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.
The prospective, randomized, controlled study involves the enrollment of cataract patients
with corneal endothelial dysfunction. All the patients will be randomly assigned with equal
probability to the following two groups: 1. Staged group: phacoemulsification + IOL
implantation is performed individually and DMEK is performed secondarily according to the
corneal status of patients. During cataract surgery, viscoelastic materials and anterior
lens capsule are used to protect the compromised corneal endothelium during
phacoemulsification. After phacoemulsification and removal of all the lens material, a
one-piece foldable IOL is implanted into the lens capsule. 2: Combined group:
phacoemulsification + IOL implantation and DMEK is performed simultaneously. Standard
procedures of phacoemulsification + IOL implantation are the same as in the staged group.
Patients enrolled into the study will be followed for one year and will have study visits at
1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04685538 -
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
|
Phase 3 | |
| Recruiting |
NCT06060041 -
IC-8 Apthera IOL New Enrollment Post Approval Study
|
||
| Recruiting |
NCT05518539 -
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
|
||
| Recruiting |
NCT05271942 -
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
|
N/A | |
| Active, not recruiting |
NCT04778501 -
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia
|
N/A | |
| Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
| Completed |
NCT03751033 -
Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
|
N/A | |
| Completed |
NCT02529488 -
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
|
N/A | |
| Completed |
NCT04539548 -
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
|
Phase 3 | |
| Completed |
NCT03740659 -
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
|
Phase 2 | |
| Completed |
NCT03494257 -
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|
N/A | |
| Completed |
NCT05119127 -
Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
|
N/A | |
| Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
| Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
| Completed |
NCT03739528 -
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
|
Phase 3 | |
| Completed |
NCT02888210 -
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
|
Phase 3 | |
| Completed |
NCT03356847 -
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
|
N/A | |
| Completed |
NCT04332640 -
Clinical Evaluation of the Next Generation Phaco System
|
N/A | |
| Recruiting |
NCT03638726 -
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
|
Phase 4 | |
| Completed |
NCT03050697 -
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
|
N/A |