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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staged group | Active Comparator | Procedure/Surgery: Phacoemulsification + IOL implantation is performed in the first stage and DMEK is performed secondarily. |
|
| Combined group | Active Comparator | Procedure/Surgery: Phacoemulsification + IOL implantation and DMEK are performed simultaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staged phacoemulsification and DMEK | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujuan Wang, M.D., Ph.D. | Contact | 8618620717002 | yujuanwang2013@gmail.com | |
| Ting Huang, M.D., Ph.D. | Contact | 862087331540 | thuang@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, M.D., Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19878827 | Background | Wang Y, Xia Y, Zeng M, Liu X, Luo L, Chen B, Liu Y, Liu Y. Torsional ultrasound efficiency under different vacuum levels in different degrees of nuclear cataract. J Cataract Refract Surg. 2009 Nov;35(11):1941-5. doi: 10.1016/j.jcrs.2009.05.055. | |
| 19139335 | Background | Huang T, Wang Y, Ji J, Gao N, Chen J. Deep lamellar endothelial keratoplasty for iridocorneal endothelial syndrome in phakic eyes. Arch Ophthalmol. 2009 Jan;127(1):33-6. doi: 10.1001/archophthalmol.2008.537. |
| Label | URL |
|---|---|
| Zhongshan Ophthalmic Center website | View source |
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|
| Combined phacoemulsification and DMEK | Procedure | Routine phacoemulsification and DMEK are performed simultaneously. |
|
| Intraocular lens (IOL) implantation | Device | After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule. |
|
| 22310081 | Background | Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4. |
| 19548882 | Background | Xia Y, Liu X, Luo L, Zeng Y, Cai X, Zeng M, Liu Y. Early changes in clear cornea incision after phacoemulsification: an anterior segment optical coherence tomography study. Acta Ophthalmol. 2009 Nov;87(7):764-8. doi: 10.1111/j.1755-3768.2008.01333.x. Epub 2009 Jun 22. |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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