An Exploratory Study of Visual Function Rehabilitation in Patients With Ocular Trauma

NCT06174415 | Unknown

• 1 other identifier: 2023KYPJ122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Ocular trauma is one of the leading causes of blindness worldwide, often resulting in severe visual impairment or even loss of vision after injury. Although after powerful surgical treatment, there are still some patients whose visual function is difficult to improve, and the patients with eye trauma lack effective vision rehabilitation therapy.Therefore, the research on visual function rehabilitation of patients with ocular trauma needs to be further carried out . Perceptual learning is based on cortical remodeling, repetitive visual task training. This training is to perform a series of repetitive visual tasks through the Gabor patch, simulating the receptive field structure of simple cells in the primary visual cortex (V1 area), "awakening visual cells", and improving the visual processing ability of the cerebral cortex. Compared with the traditional vision rehabilitation therapy, perceptual learning optimizes the visual quality at the visual center level. It is an innovative therapy, having the potential to solve the visual function of patients with eye trauma. This study intends to explore new visual rehabilitation methods for patients with ocular trauma, and explore the changes in visual cortical function and area of patients after perceptual training.

Conditions

Eye Injuries

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  Log MAR

  3 months

Secondary Outcomes (1)

• Contrast Sensitivity Function

  3 months

Study Arms (1)

Experimental group

EXPERIMENTAL

The experimental group consisted of the patients themselves. Compare data before and after treatment

Device: Perceptual Learning

Interventions

Perceptual Learning DEVICE

Perceptual training is carried out at home once a day, and the viewing distance of the patients from the display screen is uniformly 1.5m, 30 minutes each time, for three months, and they return to the hospital for re-examination of ophthalmology at the 3rd months after the training. When using the perceptual training program for the first time, the training program will adjust the size of the Gabor spot according to the size of the user's computer, and prompt the patient to adjust the brightness of the computer screen to unify the Gabor spot parameters of each user and ensure the consistency of the spot stimulation information received by each user.

Experimental group

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Retinopathy, optic neuropathy, endophthalmitis and other injuries caused by ocular trauma, with varying degrees of central vision reduction and visual field impairment
• Age 3\~60 years old
• Best corrected visual acuity of the affected eye: 20/200≤BCVA≤20/25
• Intraocular pressure is normal, non-hypotonal/atrophic: 7--21mmHg
• After the traumatic injury, the condition is stable ≥for 3 months after treatment, and the visual axis has a complete and transparent optical pathway
• If the patient is injured in one eye, There were no abnormal lesions in the contralateral eye, no abnormalities in slit lamp and indirect ophthalmoscopy, and no peripheral retinopathy in both eyes was found on triprimmoscopy. Carefully ask for a history of no other eye disease in both eyes and a systemic history that has caused an associated eye disease or has affected visual formation.
• The cranial structure is intact, the function is good, and there is no primary or secondary injury
• Able to cooperate with the questionnaire and treatment, good compliance
• Those who are willing to sign the informed consent form

You may not qualify if:

• Have active inflammation of the eye
• Previous abnormal intraocular blood supply such as occlusion of the central intraocular artery due to trauma or non-traumatic factors
• History of other non-traumatic intraocular surgery
• Ocular related lesions caused by other non-traumatic factors that can interfere with this study, such as age-related macular degeneration, glaucoma, amblyopia, etc.
• Use of other rehabilitation training methods or visual aids 3 months before enrollment
• Lesions with systemic diseases whose degree of lesions have affected visual function, such as diabetic retinopathy, Hypertension and arteriosclerotic fundus changes, rubella-related ocular changes, etc.
• Patients with severe systemic diseases such as renal failure and malignant hypertension or may affect visual function (such as retinal structure and function, choroidal structure and function, etc.)
• Patients with congenital ocular lesions
• Patients with optic nerve and retinopathy caused by non-traumatic factors
• Patients with cranial brain disease or craniocere-related lesions with poor cortical function
• Psychological related diseases
• MRI contraindications, Such as claustrophobia and non-MRI compatible metal implants
• people with speech impairment and intellectual disability
• those who are considered inappropriate by the investigator

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhonshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Eye Injuries

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Eye Diseases; Wounds and Injuries

Study Officials

• XUEYING ZHONGLIU

  Zhonshan Ophthalmic Center, Sun-Yat-sen University Organization

  STUDY DIRECTOR

Central Study Contacts

WANQI QIAN

CONTACT

0086-15765304712; qianwanqi618@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparing the data before and after treatment

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: December 30, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-05

Locations

CN (1)