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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Implantable collamer lens (ICL) implantation is considered one of the most effective surgical treatments for high myopia. The procedure primarily involves adjusting the position of the ICL within the eye. However, precise calculation of the ICL optical power may cause the surgical light source to remain focused on the macular area during this process, potentially leading to iatrogenic light-induced damage. Theoretically, the combination of a 3D visualization surgical system and coaxial illumination technology can reduce the illumination intensity and decrease iatrogenic light damage. This study aims to compare the retinal physiological changes in patients undergoing ICL surgery through 3D visualization surgical system with coaxial illumination versus a traditional microscope with standard illumination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D visualization system | Experimental |
| |
| Microscope | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D visualization system with coaxial illumination | Procedure | operation through 3D visualization system with coaxial illumination |
|
| Measure | Description | Time Frame |
|---|---|---|
| b-wave amplitude | 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| a-wave amplitude | 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op | |
| macular vessel density | 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op | |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative illumination intensity | surgery beginning | |
| Surgical time | Starting with the making of the surgical incision and ending with incision closure |
Inclusion Criteria:
Exclusion Criteria:
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| microscope with standard illumination | Procedure | operation through microscope with standard illumination |
|
| Uncorrected visual acuity |
| 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op |
| Best-corrected visual acuity | 1 day pre-op; 1 day post-op; 7 days post-op; 30 days post-op |