The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03603067
• Other study ID #: SHIRB2018018
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2018
• Source: Aier School of Ophthalmology, Central South University
• Contact: Zhuyun A Qian
• Phone: +8613817109809
• Email: qianzhuyun552[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychology, Social
• Surgery

Intervention

Procedure:
• Ocular surgery
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.

Locations

Country	Name	City	State
China	Shanghai Aier Eye Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	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	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.