Skip to content

The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03603067
Enrollment
60
Registered
2018-07-27
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychology, Social, Surgery

Keywords

monophthalmos, social psychology, ocular surgery

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.

Interventions

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.

Sponsors

Aier School of Ophthalmology, Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Level of anxietyChange 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 depressionChange 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

MeasureTime frameDescription
Level of social supportChange 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.

Other

MeasureTime frameDescription
Visual functionOne day before surgery and one day, one months, three months and six months after surgery.BCVA and intraocular pressure (IOP) wlll be recorded.

Countries

China

Contacts

Primary ContactZhuyun A Qian
qianzhuyun552@126.com+8613817109809
Backup ContactWensheng A Li
drlws@qq.com+8618650424985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026