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Sample size estimation for AQP4-IgG seropositive optic neuritis: Retinal damage detection by optical coherence
1Department of Ophthalmology, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, No. 19 Renmin Road, Zhengzhou 450099, China.
Open Life Sciences
|April 18, 2024
Summary
Glucocorticoid treatment did not prevent retinal thinning in aquaporin-4 seropositive optic neuritis patients. Optical coherence tomography revealed significant macular ganglion cell layer plus inner plexiform layer (mGCIPL) loss, necessitating a large sample size for future clinical trials.
Area of Science:
- Ophthalmology
- Neuroscience
- Immunology
Background:
- Optic neuritis is an inflammatory condition affecting the optic nerve.
- Aquaporin-4 antibodies are associated with a specific subtype of optic neuritis, often linked to neuromyelitis optica spectrum disorder.
- Glucocorticoid therapy is a standard treatment for optic neuritis, but its long-term effects on retinal structure are not fully understood.
Purpose of the Study:
- To investigate the structural changes in the retina, specifically the macular ganglion cell layer plus inner plexiform layer (mGCIPL), in patients with aquaporin-4 seropositive optic neuritis.
- To assess the impact of glucocorticoid treatment on mGCIPL thickness and volume over a 6-month period.
- To estimate the required sample size for future clinical trials investigating interventions for this patient population.
Main Methods:
- Recruitment of four aquaporin-4 seropositive optic neuritis patients (five eyes) receiving glucocorticoid treatment.
- Optical coherence tomography (OCT) examination to measure mGCIPL thickness and volume at baseline, 2 months, and 6 months.
- Sample size calculation using two distinct methods based on mGCIPL thickness and volume data, considering various effect sizes.
Main Results:
- A significant reduction in mGCIPL thickness and volume was observed from baseline to 6 months post-treatment.
- Baseline median mGCIPL thickness was 79.67 µm, decreasing to 59.55 µm at 6 months.
- Sample size estimation indicated a need for 206 patients for a 6-month follow-up study with 80% power and a 20% effect size based on mGCIPL volume.
Conclusions:
- Optical coherence tomography effectively detected retinal damage, evidenced by mGCIPL thinning, in aquaporin-4 seropositive optic neuritis patients despite glucocorticoid treatment.
- The findings highlight the potential for progressive retinal neurodegeneration in this condition.
- The study provides crucial sample size estimations for designing future clinical trials focused on neuroprotective or regenerative therapies in this specific patient group.
