The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

NCT ID: NCT03603067

Last Updated: 2018-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

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.

Conditions

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Psychology, Social Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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monophthalmic group

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.

Ocular surgery

Intervention Type PROCEDURE

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.

Normal group

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.

Ocular surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wensheng Li

Role: STUDY_DIRECTOR

Shanghai Aier Eye Hospital

Locations

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Shanghai Aier Eye Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhuyun A Qian

Role: CONTACT

+8613817109809 ext. +8613817109809

Wensheng A Li

Role: CONTACT

+8618650424985 ext. +8618650424985

Facility Contacts

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Zhuyun Qian

Role: primary

+8613817109809

Wensheng Li

Role: backup

+8618650424985

References

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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.

Reference Type BACKGROUND
PMID: 19929654 (View on PubMed)

Other Identifiers

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SHIRB2018018

Identifier Type: -

Identifier Source: org_study_id

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