Staged and Combined Surgery for Cataract Patients With Corneal Endothelial Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Staged and Combined Phacoemulsification With Intraocular Lens (IOL) Implantation and Descemet Membrane Endothelial Keratoplasty (DMEK) for Cataract Patients With Corneal Endothelial Dysfunction

Conditions
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Cataract, Corneal Endothelial Keratopathy, Phacoemulfisication+IOL Implantation, Endothelial Keratopathy

Intervention / Treatment
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* Procedure: Staged phacoemulsification and DMEK
* Procedure: Combined phacoemulsification and DMEK
* Device: Intraocular lens (IOL) implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are older than 18 years. Subjects have corneal endothelial dysfunction combined with cataract. Subjects have mild to moderate cortical and/or nuclear cataract. Subjects are able and willing to provide informed consent. Exclusion Criteria: Subjects have corneal stromal opacity and/or neovascularization. Subjects have other intraocular disease that disturbs visual rehabilitation. Subjects have corneal infection, perforation or scarring. Subjects are pregnant. Subjects have concurrent disease that could confound the response to therapy. Subjects are unlikely to comply with the protocol or likely to be lost to follow-up. Subjects have known hypersensitivity or intolerance to the proposed therapy. Subjects use concomitant therapy that affects either tear function or ocular surface integrity. Subjects have had surgical or other manipulation of the eye that could confound the outcome parameters or interfere with the mechanism of action of the proposed intervention to be studied.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staged group<br>Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily. | Procedure: Staged phacoemulsification and DMEK<br>* Stage 1. Phacoemulsification is performed individually. During phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells. Stage 2. DMEK is performed secondarily according to the corneal status of patients.<br>Device: Intraocular lens (IOL) implantation<br>* After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.<br>|
| Active Comparator: Combined group<br>Procedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously. | Procedure: Combined phacoemulsification and DMEK<br>* Routine phacoemulsification and DMEK are performed simultaneously.<br>Device: Intraocular lens (IOL) implantation<br>* After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in visual acuity measured by Snellen chart |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery | 
| Change from baseline in central corneal thickness measured by anterior segment OCT |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery | 
| Change from baseline in endothelial cell density measured by corneal specular microscopy |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in endothelial graft attachment measured by anterior segment OCT |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery | 
| Change from baseline in corneal transparency measured by slit-lamp microscopy |  | 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery |