OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in Retinal Photo-injury

NCT07869511 | Recruiting

• 1 other identifier: 2026-0547
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective observational study is to evaluate the effectiveness of retrobulbar glucocorticoid injection in patients with retinal photo-injury. The main questions it aims to answer are: Does retrobulbar glucocorticoid injection improve visual outcomes in patients with retinal photo-injury? Does retrobulbar glucocorticoid injection promote recovery of retinal structural and microvascular changes assessed by optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA)? Patients with retinal photo-injury will be retrospectively identified and grouped according to the treatment they received. Clinical and ophthalmic data collected before treatment and during follow-up for up to 6 months will be reviewed, including best-corrected visual acuity (BCVA), fundus photography, spectral-domain OCT (SD-OCT), and OCTA. Visual and retinal imaging outcomes will be compared between the two groups to evaluate the potential effectiveness of retrobulbar glucocorticoid treatment.

Conditions

Retinal Light Damage; Photic Retinopathy; Photic Maculopathy

Outcome Measures

Primary Outcomes (1)

• Changes in Best-Corrected Visual Acuity (BCVA), measured in logMAR

  Best-corrected visual acuity (BCVA) will be assessed using a standardized visual acuity chart after appropriate refractive correction and recorded as a decimal visual acuity value, which will be converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis. BCVA will be assessed at baseline (before treatment) and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment. The BCVA value and the change from baseline at each follow-up time point will be summarized and compared. Lower logMAR values indicate better visual acuity.

  Before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment

Secondary Outcomes (1)

• Changes in Central Subfield Thickness, Ellipsoid Zone Defect Length, and Outer Nuclear Layer Thickness Measured by Optical Coherence Tomography

  Before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment

Study Arms (2)

Local hormone treatment group

Patients with retinal photic injury who only received intravitreal corticosteroid injections during their initial visit and follow-ups were placed in the local hormone treatment group.

Drug: retrobulbar injection of glucocorticoid

Non-hormone treatment group

Patients with retinal light damage who didn't use any systemic or local corticosteroid treatment at their first visit or during follow-ups were placed in the non-hormone treatment group.

Interventions

retrobulbar injection of glucocorticoid DRUG

Retrobulbar injection of Methylprednisolone （40mg/ml） once a week, or triamcinolone （40mg/ml） every 2-3 weeks, no more than 3 times in a row. For children, the dose should be halved or the interval extended, and closely watch for any side effects after injection.

Local hormone treatment group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with retinal photic injury

You may qualify if:

• The diagnosis was established based on a history of exposure to a high-intensity light source and clinical manifestations such as metamorphopsia and reduced visual acuity, combined with findings from fundus examination and OCT-specifically, disruption or defects in the photoreceptor inner/outer segment (IS/OS) junction and the retinal pigment epithelium (RPE) layer within the macular region.
• The included patient should meet the aforementioned diagnostic criteria, and was diagnosed with retinal photic injury.

You may not qualify if:

• Unable or unwilling to sign the informed consent form, or unable to adhere to study procedures.
• Patients have conditions that significantly interfere with OCTA imaging, such as severe corneal opacity, cataracts, or vitreous hemorrhage.
• Patients who develop other concurrent eye diseases or severe comorbidities requiring immediate treatment during the follow-up period-such as glaucoma, uveitis, scleritis, retinal detachment, optic neuritis, diabetic retinopathy, macular hole, retinal neovascularization, sclerosis, Parkinson's disease, or other disorders affecting the retina and optic nerve.
• History of intraocular surgery or ocular trauma.
• Severe systemic diseases (e.g., serious cardiovascular, cerebrovascular, or hematopoietic disorders), or a history of intracranial surgery or intracranial space-occupying lesions.
• Inability to cooperate with ophthalmic examinations or failure to obtain satisfactory OCTA images for other reasons.
• Pregnant women, women planning pregnancy or breastfeeding, and patients with drug allergies.
• Suspected or confirmed history of alcohol or drug abuse.
• Patients currently participating in other clinical trials involving medications.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Foveomacular Retinitis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

zhiyong zhang

CONTACT

+86 13968059392; zhangzhiyong@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: October 9, 2026
• Study Start: October 9, 2026
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): October 9, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-08

Locations

CN (1)