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

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Psychology, Social
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Zhuyun A Qian; Phone Number: +8613817109809 +8613817109809; Email: qianzhuyun552@126.com
• Study Contact Backup: Name: Wensheng A Li; Phone Number: +8618650424985 +8618650424985; Email: drlws@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Aier Eye Hospital
      • Contact: Zhuyun Qian; Phone Number: +8613817109809; Email: qianzhuyun552@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Aier School of Ophthalmology, Central South University
• Investigators: Study Director: Wensheng Li, Shanghai Aier Eye Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: July 7, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (ACTUAL): July 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: social psychology; ocular surgery; monophthalmos
• Other Study ID Numbers: SHIRB2018018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will be partly shared in published papers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No