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| Name | Class |
|---|---|
| Staar Surgical Company | INDUSTRY |
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The objective is to conduct a contralateral prospective clinical study to compare the safety, efficacy, and quality of vision of the STAAR Surgical Co. Toric Implantable Contact Lens TICL) versus Custom Laser Vision Correction (Q-LASIK) in human eyes for the correction of myopia with astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TICL group | Experimental |
| |
| LASIK group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the implantation of toric implantable collamer lens | Procedure | perform the implantation of toric implantable collamer lens for both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the efficacy, predictability, stability and safety of TICL versus Q-LASIK | 1week, 1,3,6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing wavefront aberrometry of TICL vs Q-LASIK Comparing contrast sensitivity of TICL vs Q-LASIK Comparing patient satisfaction of TICL vs Q-LASIK | 1, 3, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qin Mei Wang | Eye hospital of Wenzhou Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye hospital of Wenzhou Medical College | Wenzhou | Zhejiang | 325027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17598571 | Background | Sanders DR. Matched population comparison of the Visian Implantable Collamer Lens and standard LASIK for myopia of -3.00 to -7.88 diopters. J Refract Surg. 2007 Jun;23(6):537-53. doi: 10.3928/1081-597X-20070601-02. | |
| 17172886 | Background | Sanders D, Vukich JA. Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia. Cornea. 2006 Dec;25(10):1139-46. doi: 10.1097/ICO.0b013e31802cbf3c. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 7, 2011 | |
| Reset | May 3, 2011 |
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| customized laser-assisted in situ keratomileusis | Procedure | perform Q-factor customized laser-assisted in situ keratomileusis for both eyes |
|
|
| 12792475 | Background | Sanders DR, Vukich JA. Comparison of implantable contact lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 2003 May;22(4):324-31. doi: 10.1097/00003226-200305000-00009. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2011 | May 3, 2011 |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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