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This study is designed to evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision.
Monophthalmos means the best corrected visual acuity (BCVA) of the worse eye is less than 0.05 or the central visual field (CFOV) is less than 5°. The ocular surgery of the better eye in monophthalmic patients is of high risk. On the one hand the surgical failure will result in the patient falling into permanent darkness. On the other hand the monophthalmic patient may have the same disease in both two eyes such as high axial myopia, uveitis and glaucoma, which will increase the surgical risk. There is still no consensus on whether it is necessary to take risks to perform this kind of operation. In this study we will evaluate the change of psychological status before and after surgery in monophthalmic patients who receive the ocular surgery in eye with better vision. The necessity of the ocular surgery in monophthalmic patients will be evaluated from the point of social psychology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monophthalmic group | The BCVA of the worse eye is less than 0.05 or CFOV is less than 5°. The better eye need to receive ocular surgery. |
| |
| Normal group | The BCVA of the worse eye is more than 0.3 and CFOV is more than 10°. One of two eyes need to receive ocular surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular surgery | Procedure | Different ocular surgeries (including vitreoretinal surgery, cataract surgery, anti-glaucoma surgery etc) will be performed in one eye of the patient. In monophthalmic patient group the surgery will be performed in eye with better visual acuity. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of anxiety | Hamilton anxiety scale（HAMA）will be filled in by each patient and the final score will be recorded. The total score ranges from 0-56. A score less than 7 means no symptom of anxiety. A score between 7 to 14 means possible anxiety. A score between 14-21 means mild anxiety. A score between 21-29 means moderate anxiety. A score more than 29 means severe symptom of anxiety. | Change from Baseline HAMA score at 6 months. |
| Level of depression | Hamilton depression scale (HAMD) will be filled in by each patient and the final score will be recorded. The total score ranges from 0-56. A score less than 8 means no symptom of depression. A score between 8 to 35 means mild or moderate depression. A score more than 35 means severe symptom of depression. | Change from Baseline HAMD score at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of social support | Social support rating scale (SSRS) will be filled in by each patient and the final score will be recorded. | Change from Baseline SSRS score at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual function | BCVA and intraocular pressure (IOP) wlll be recorded. | One day before surgery and one day, one months, three months and six months after surgery. |
Inclusion Criteria:
Exclusion Criteria:
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Patients hospitalized in Shanghai Aier Eye Hospital and are intended to receive ocular surgery in one of two eyes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuyun A Qian | Contact | +8613817109809 | +8613817109809 | qianzhuyun552@126.com |
| Wensheng A Li | Contact | +8618650424985 | +8618650424985 | drlws@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Wensheng Li | Shanghai Aier Eye Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Aier Eye Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19929654 | Background | Hirneiss C, Neubauer AS, Herold TR, Kampik A, Hintschich C. Utility values in patients with acquired anophthalmus. Orbit. 2009;28(6):332-6. doi: 10.3109/01676830903104702. |
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Individual participant data will be partly shared in published papers.
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| ID | Term |
|---|---|
| C562573 | cyclopia sequence |
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| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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