The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

• Conditions: Psychology, Social; Surgery
• Interventions: Procedure: Ocular surgery

• Registration Number: NCT03603067
• Lead Sponsor: Aier School of Ophthalmology, Central South University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-06
• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
monophthalmic group	Ocular surgery	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	Ocular surgery	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.

Primary Outcome Measures

Name	Time	Method
Level of anxiety	Change from Baseline HAMA score at 6 months.	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.
Level of depression	Change from Baseline HAMD score at 6 months.	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.

Secondary Outcome Measures

Name	Time	Method
Level of social support	Change from Baseline SSRS score at 6 months.	Social support rating scale (SSRS) will be filled in by each patient and the final score will be recorded.

Trial Locations

Locations (1)

Shanghai Aier Eye Hospital; 🇨🇳 Shanghai, Shanghai, China