The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Non-randomized, Controlled Study: To Evaluate the Psychological Status of Monophthalmic Patients Before and After Ocular Surgery

Conditions
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Surgery, Psychology, Social

Intervention / Treatment
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* Procedure: Ocular surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intention to receive ocular surgery in one of two eyes. Free from prior mental disorders. Without general disease and can tolerate the operation. Communication without difficulty. Exclusion Criteria: With prior mental disorders. Can not tolerate the operation. Communication with difficulty.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| monophthalmic group<br>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. | Procedure: Ocular surgery<br>* 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.<br>|
| Normal group<br>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. | Procedure: Ocular surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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monophthalmos, social psychology, ocular surgery