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The Study of Psychological Status in Monophthalmic Patients With Ocular Surgery

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ClinicalTrials.gov Identifier: NCT03603067
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Psychology, Social Surgery Procedure: Ocular surgery

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-randomized, Controlled Study: To Evaluate the Psychological Status of Monophthalmic Patients Before and After Ocular Surgery
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Level of social support [ Time Frame: 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.


Other Outcome Measures:
  1. Visual function [ Time Frame: One day before surgery and one day, one months, three months and six months after surgery. ]
    BCVA and intraocular pressure (IOP) wlll be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in Shanghai Aier Eye Hospital and are intended to receive ocular surgery in one of two eyes.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603067


Contacts
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Contact: Zhuyun A Qian +8613817109809 ext +8613817109809 qianzhuyun552@126.com
Contact: Wensheng A Li +8618650424985 ext +8618650424985 drlws@qq.com

Locations
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China, Shanghai
Shanghai Aier Eye Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Zhuyun Qian    +8613817109809    qianzhuyun552@126.com   
Contact: Wensheng Li    +8618650424985    drlws@qq.com   
Sponsors and Collaborators
Aier School of Ophthalmology, Central South University
Investigators
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Study Director: Wensheng Li Shanghai Aier Eye Hospital

Publications:
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Responsible Party: Aier School of Ophthalmology, Central South University
ClinicalTrials.gov Identifier: NCT03603067    
Other Study ID Numbers: SHIRB2018018
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be partly shared in published papers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aier School of Ophthalmology, Central South University:
monophthalmos
social psychology
ocular surgery