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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 7, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJuly 27, 2018
June 1, 2018
1.5 years
July 7, 2018
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (1)
Level of social support
Change from Baseline SSRS score at 6 months.
Other Outcomes (1)
Visual function
One day before surgery and one day, one months, three months and six months after surgery.
Study Arms (2)
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.
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.
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.
Eligibility Criteria
Patients hospitalized in Shanghai Aier Eye Hospital and are intended to receive ocular surgery in one of two eyes.
You may qualify if:
- 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.
You may not qualify if:
- With prior mental disorders.
- Can not tolerate the operation.
- Communication with difficulty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Aier Eye Hospital
Shanghai, Shanghai Municipality, 200000, China
Related 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.
PMID: 19929654BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wensheng Li
Shanghai Aier Eye Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2018
First Posted
July 27, 2018
Study Start
January 1, 2018
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
July 27, 2018
Record last verified: 2018-06