Trial · NCT03811366
Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
NCT03811366, Not applicable, Completed, University of Sao Paulo; results first posted 2024-11-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I. Trials, record NCT03811366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03811366
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
- NCT number
- NCT03811366
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 12 participants, actual
- Lead sponsor
- University of Sao Paulo
- Conditions
- Uveomeningoencephalitic Syndrome, Inflammation, Choroid Disease, Visual Impairment
- Interventions
- Corticosteroid monotherapy
- First posted
- 2019-01-22
- Last updated
- 2025-04-17
- Results first posted
- 2024-11-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Values of ERG Scotopic Parameters at 12-month | assessed at 12-month | Full-field electroretinogram (ERG) scotopic parameters were evaluated at 12 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential). |
| Primary | Median Values of ERG Scotopic Parameters at 24-month | assessed at 24-month | Full-field electroretinogram (ERG) scotopic parameters were evaluated at 24 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential). |
| Primary | Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months | 12 and 24-months | Full-field electroretinogram (ERG) scotopic parameters at 12 and 24 months were compared (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential). The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any these scotopic ERG parameters at month 12 and month 24. We report the change between the (value at month 24/ the value at month 12)\*100. |
| Secondary | Recurrence or Worsening of Cells in Anterior Chamber | 6 to 24 months from disease onset. | Evaluation of anterior chamber (AC) cells was performed at visits 6 months, 12 months, 18 months and 24 months from disease onset, according to the Standardization of Uveitis Nomenclature´s classification of anterior chamber cells. (Am J Ophthalmol, 2005) Any step increase (fluctuation), when comparing sequential dates of follow up (e.g 6 and 12 months) were considered as one episode of clinical worsening in AC cells |
| Secondary | Increase in the Score of Dark Dots on Indocyanine Green Angiography | 6 to 24 months from disease onset | Dark dots scores had a maximum value of 8, any increase of 0.5 after 6 months from disease onset will be considered (Int Ophthalmo 2010) Dark dots Score based on pattern of distribution (Sparse/ Numerous) Minimum: 0 (better outcome) Maximum: 8 (worse outcome) |
| Secondary | Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography | 6 to 24 months from disease onset | Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan |
| Secondary | Change in Perivascular Leakage on Fluorescein Angiography | 6 to 24 months after disease onset | Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery. |
| Secondary | Choroidal Neovascularization | 6 to 24 months after disease onset | Choroidal neovascularization was diagnosed when increasingly localized hyperfluorescence at the posterior pole is detected on FA or a hyperreflective subretinal lesion associated with sub or intraretinal fluid on OCT. |
| Secondary | Cataract | 6 to 24 months after disease onset | Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4 |
| Secondary | Ocular Hypertension | 6 to 24 months after disease onset | Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Values of ERG Scotopic Parameters at 12-month | assessed at 12-month | microvolts | MEDIAN | |
| PRIMARY | Median Values of ERG Scotopic Parameters at 24-month | assessed at 24-month | microvolts | MEDIAN | |
| PRIMARY | Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months | 12 and 24-months | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | percentage of change on ERG parameters | NUMBER |
| SECONDARY | Recurrence or Worsening of Cells in Anterior Chamber | 6 to 24 months from disease onset. | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | COUNT_OF_UNITS |
| SECONDARY | Increase in the Score of Dark Dots on Indocyanine Green Angiography | 6 to 24 months from disease onset | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | NUMBER |
| SECONDARY | Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography | 6 to 24 months from disease onset | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | COUNT_OF_UNITS |
| SECONDARY | Change in Perivascular Leakage on Fluorescein Angiography | 6 to 24 months after disease onset | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | COUNT_OF_UNITS |
| SECONDARY | Choroidal Neovascularization | 6 to 24 months after disease onset | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | NUMBER |
| SECONDARY | Cataract | 6 to 24 months after disease onset | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | NUMBER |
| SECONDARY | Ocular Hypertension | 6 to 24 months after disease onset | One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants | eyes | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Scotopic b amplitude | 201 | Full Range 104 to 352 | microvolts |
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Maximum scotopic a amplitude | 210 | Full Range 134 to 336 | microvolts |
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Maximum scotopic b amplitude | 508 | Full Range 328 to 728 | microvolts |
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Oscillatory potential | 92 | Full Range 48 to 272 | microvolts |
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Photopic a amplitude | 42 | Full Range 23 to 63 | microvolts |
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Photopic B amplitude | 202 | Full Range 87 to 312 | microvolts |
| Median Values of ERG Scotopic Parameters at 12-month | Corticosteroid Monotherapy | Flicker | 52 | Full Range 24 to 89 | microvolts |
| Median Values of ERG Scotopic Parameters at 24-month | Corticosteroid Monotherapy | Scotopic b amplitude | 189 | Full Range 130 to 380 | microvolts |
| Median Values of ERG Scotopic Parameters at 24-month | Corticosteroid Monotherapy | Maximum scotopic a amplitude | 189 | Full Range 120 to 317 | microvolts |
| Median Values of ERG Scotopic Parameters at 24-month | Corticosteroid Monotherapy | Maximum scotopic b amplitude | 484 | Full Range 336 to 789 | microvolts |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Corticosteroid Monotherapy | 12 | 24 |
| Overall Study | COMPLETED | Corticosteroid Monotherapy | 12 | 24 |
| Overall Study | NOT COMPLETED | Corticosteroid Monotherapy | 0 | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Psychosis/ depression | Psychiatric disorders | Corticosteroid Monotherapy | 2 | 12 | 2 |
| other | Weight gain | General disorders | Corticosteroid Monotherapy | 4 | 12 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Corticosteroid Monotherapy | 0 | 12 |
| Total, other adverse events | Corticosteroid Monotherapy | 6 | 12 |
| Total, serious adverse events | Corticosteroid Monotherapy | 0 | 12 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03811366
GET https://conductscience.org/api/trials/v1/NCT03811366/results?page=2