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Clinical Trials/NCT03603067
NCT03603067
Unknown
Not Applicable

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

Aier School of Ophthalmology, Central South University1 site in 1 country60 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychology, Social
Sponsor
Aier School of Ophthalmology, Central South University
Enrollment
60
Locations
1
Primary Endpoint
Level of anxiety
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aier School of Ophthalmology, Central South University
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Level of anxiety

Time Frame: 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

Time Frame: 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 Outcomes

  • Level of social support(Change from Baseline SSRS score at 6 months.)

Study Sites (1)

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