Retinal Light DamageNCT07869511
OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in Retinal Photo-injury
An observational study of Retinal Light Damage and Photic Retinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Retinal Light Damage, Photic Retinopathy, Photic Maculopathy
- What is being tested?
- retrobulbar injection of glucocorticoid
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2026to 9 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed with retinal photic injury
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
zexin chen, +86 0571-87783914, keyanlunli_zheer@163.com
About this study
Official title: OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in the Treatment of Retinal Photo-injury
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
- Being tested
- retrobulbar injection of glucocorticoid
- Medical subject headings
- Foveomacular Retinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrobulbar injection of glucocorticoidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Retinal structural changes will be assessed using optical coherence tomography (OCT). The following quantitative parameters will be measured: central subfield thickness (CST, μm), maximum horizontal length of the ellipsoid zone (EZ) defect (μm), and foveal outer nuclear layer (ONL) thickness (μm). Measurements will be obtained at baseline (before treatment) and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment. Each parameter and its change from baseline at each follow-up time point will be summarized and compared to evaluate retinal structural recovery following treatment.
Measured: Before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start9 Oct 2026 (estimated)
- Primary completion9 Oct 2027 (estimated)
- Study completion9 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Light DamageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869511
- Sponsor's protocol ID
- 2026-0547
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTA Evaluated the Efficacy of Glucocorticoid Retrobulbar Injection in the Treatment of Retinal Photo-injury
- ClinicalTrials.gov ID
- NCT07869511
- Acronym / sponsor ID
- 2026-0547
- Conditions
- Retinal Light Damage, Photic Retinopathy, Photic Maculopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Oct 2026 (estimated)
- Primary completion
- 9 Oct 2027 (estimated)
- Study completion
- 9 Oct 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local hormone treatment group | – | Drug: retrobulbar injection of glucocorticoidPatients 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. |
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with retinal photic injury
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrobulbar injection of glucocorticoidRetrobulbar 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. | Drug | Local hormone treatment group |
Primary outcome
Changes in Best-Corrected Visual Acuity (BCVA), measured in logMAR
Time frame: Before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment
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.
1 secondary outcome
Changes in Central Subfield Thickness, Ellipsoid Zone Defect Length, and Outer Nuclear Layer Thickness Measured by Optical Coherence Tomography
Time frame: Before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Light Damage and Photic Retinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhiyong zhang (+86 13968059392, zhangzhiyong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Best-Corrected Visual Acuity (BCVA), measured in logMAR (time frame: Before treatment and at 1 week, 2 weeks, 1 month, 3 months, and 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.