Trial · NCT07897513
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Aqueous humor bacterial richness measured by the abundance-based coverage estimator (ACE) | Baseline | The abundance-based coverage estimator (ACE) will be calculated for each baseline aqueous humor sample using quality-controlled, contamination-filtered 16S rRNA gene sequencing data. ACE estimates bacterial taxon richness; higher values indicate greater estimated richness. ACE values will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. The reported measure is the ACE estimate, expressed as estimated taxon richness. |
| Primary | Aqueous humor bacterial alpha diversity measured by the Shannon index | Baseline | The Shannon diversity index will be calculated for each baseline aqueous humor sample from quality-controlled, contamination-filtered 16S rRNA gene sequencing data. The index summarizes bacterial richness and evenness; higher values indicate greater diversity. Values will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. The reported measure is the Shannon index (dimensionless). |
| Primary | Aqueous humor bacterial beta diversity measured by Jaccard dissimilarity | Baseline | Pairwise Jaccard dissimilarity will be calculated from bacterial taxon presence or absence in baseline aqueous humor samples after quality control and contamination filtering of 16S rRNA gene sequencing data. The measure ranges from 0 (identical detected taxa) to 1 (no shared detected taxa) and is dimensionless. Community composition will be compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. Ordination and permutation tests are analysis methods, not additional outcomes. |
| Primary | Relative abundance of bacterial genera in aqueous humor | Baseline | Bacterial genera will be identified in baseline aqueous humor by 16S rRNA gene sequencing after quality control and contamination filtering. For each genus, relative abundance is 100 times its assigned bacterial abundance divided by the total assigned bacterial abundance in that sample, expressed as a percentage. Each genus will be reported separately and compared among age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, central serous chorioretinopathy, and cataract control groups. Genera will not be combined into a composite score. |
| Secondary | Correlation between aqueous humor bacterial genera and aqueous humor proteins | Baseline | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and protein abundance measured by targeted proteomic analysis of the paired aqueous humor sample. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure. |
| Secondary | Correlation between aqueous humor bacterial genera and peripheral blood mononuclear cell transcripts | Baseline | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and normalized transcript abundance measured by transcriptomic analysis of peripheral blood mononuclear cells. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure. |
| Secondary | Correlation between aqueous humor bacterial genera and plasma metabolites | Baseline | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and normalized metabolite abundance measured by metabolomic analysis of plasma. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure. |
| Secondary | Correlation between aqueous humor bacterial genera and fecal metabolites | Baseline | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and normalized metabolite abundance measured by metabolomic analysis of fecal samples. Samples will be collected at baseline. A separate coefficient will be reported for each genus-feature pair within each disease group. Coefficients range from -1 to +1 and are dimensionless; the sign indicates direction and the absolute value indicates association strength. Network diagrams are exploratory visualizations and are not a separate reported measure. |
| Other | Difference in baseline aqueous humor bacterial genus relative abundance by 3-month anatomical response | Baseline aqueous humor sampling and anatomical response assessment 3 months after index treatment initiation. | Baseline aqueous humor bacterial genus relative abundance will be measured by 16S rRNA gene sequencing. For each genus, the mean abundance difference between good and poor responders will be reported in percentage points, separately for age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, and central serous chorioretinopathy. Response will be assessed by optical coherence tomography 3 months after index treatment initiation. Good response requires complete resolution of subretinal and intraretinal fluid with no enlargement of pigment epithelial detachment. Poor response is persistent subretinal or intraretinal fluid. For neovascular age-related macular degeneration, this assessment follows three consecutive monthly anti-vascular endothelial growth factor injections. |
| Other | Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 3 | Baseline aqueous humor sampling and BCVA assessment 3 months after index treatment initiation. | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 3 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline. |
| Other | Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 6 | Baseline aqueous humor sampling and BCVA assessment 6 months after index treatment initiation. | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 6 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline. |
| Other | Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 9 | Baseline aqueous humor sampling and BCVA assessment 9 months after index treatment initiation. | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 9 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline. |
| Other | Correlation between baseline aqueous humor bacterial genera and best-corrected visual acuity at month 12 | Baseline aqueous humor sampling and BCVA assessment 12 months after index treatment initiation. | Spearman rank correlation coefficients will quantify associations between baseline aqueous humor bacterial genus relative abundance, measured by 16S rRNA gene sequencing, and best-corrected visual acuity (BCVA) 12 months after index treatment initiation. Snellen BCVA will be converted to logMAR; higher logMAR indicates worse vision. A separate coefficient will be reported for each genus within each disease group. Coefficients range from -1 to +1 and are dimensionless. Positive values indicate association with worse vision; negative values indicate association with better vision. This outcome assesses follow-up BCVA, not change from baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07897513/registered