Evidence map›Paper›PMID 27031504›Full record

Trial reportJAMA ophthalmology2016

Quantification of Ellipsoid Zone Changes in Retinitis Pigmentosa Using en Face Spectral Domain-Optical Coherence Tomography.

Amir H Hariri, Hong Yang Zhang, Alexander Ho, Peter Francis, Richard G Weleber, David G Birch, Frederick L Ferris, SriniVas R Sadda, Trial of Oral Valproic Acid for Retinitis Pigmentosa Group

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in JAMA ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05537220 (NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients With Retinitis Pigmentosa), which is not on this map. Cited by 66 papers.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05537220 phase3active not recruitingnot on this mapstarted 2023, after this paper: background citation

NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients With Retinitis Pigmentosa

TypeinterventionalSponsorJohns Hopkins UniversityRan2023 to 2030Enrolled485ConditionsRetinitis PigmentosaArmsN-acetylcysteine, Placebo
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 89 citations in OpenAlex.

  1. Trial
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  7. Chronic changes in acute zonal occult outer retinopathy mimicking non-progressive retinitis pigmentosa: clinical and laboratory characteristics.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  8. Review
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  17. Widefield OCT angiography.Progress in retinal and eye research · 2025
    Review
  18. Review
  19. Review
  20. Prognostic impact of hyperreflective foci in nonsyndromic retinitis pigmentosa.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Amir H HaririDoheny Eye Institute, Los Angeles, California2Department of Ophthalmology, David Geffen School of Medicine, University of California, Los Angeles.
Hong Yang ZhangDoheny Eye Institute, Los Angeles, California2Department of Ophthalmology, David Geffen School of Medicine, University of California, Los Angeles.
Alexander HoDoheny Eye Institute, Los Angeles, California.
Peter FrancisPacific Ophthalmology Consulting, Portland, Oregon.
Richard G WeleberCasey Eye Institute, Oregon Health & Science University, Portland.
David G BirchRetina Foundation of the Southwest, Dallas, Texas.
Frederick L FerrisDivision of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.
SriniVas R SaddaDoheny Eye Institute, Los Angeles, California2Department of Ophthalmology, David Geffen School of Medicine, University of California, Los Angeles.
Trial of Oral Valproic Acid for Retinitis Pigmentosa Group
Doheny Eye Institute · USNational Eye Institute · USOregon Health & Science University · USRetina Foundation of the Southwest · USUniversity of California, Los Angeles · US

Funding

MEASURES OF HUMAN RECEPTOR AND POST RECEPTOR ACTIVITYR01EY009076 · NEI · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI BIRCH, DAVID G, HOOD, DONALD C. · 1991 to 2021
$8.3M
NEI NIH HHS R01 EY009076
6 · The paper itself

Abstract

importanceNew methods are needed to quantify the change in the outer retinal structures in retinitis pigmentosa (RP).

objectiveTo implement an alternate method for tracking ellipsoid zone (EZ) changes in RP by quantifying the EZ area on en face spectral domain-optical coherence tomographic (SD-OCT) images. DESIGN, SETTING, AND

participantsData for this observational case study were collected at the Department of Ophthalmology, University of California, Los Angeles, from May 1 to July 30, 2015, and included SD-OCT images of a subset of patients from the Trial of Oral Valproic Acid for Retinitis Pigmentosa. To be eligible for the en face OCT subanalysis, the preserved EZ area was required to be limited to the SD-OCT scanning field. Cases in which the EZ band extended to the margins of any B-scan or the most superior or inferior B-scan were excluded. The SD-OCT images of all included cases were imported into the manufacturer's software to generate en face images at the level of the EZ. Two certified SD-OCT graders independently delineated the boundaries of the preserved EZ on the en face images. MAIN OUTCOMES AND MEASURES: Comparison of the 2 masked gradings of the generated en face images of patients with RP for agreement between the graders and the validity of the method.

resultsOf the 43 available patients with volume SD-OCT data, 45 eyes of 24 patients met the eligibility criteria and were included in this subanalysis. Every patient had 2 visits that were 1 year apart, which included a total of 90 en face OCT images that were graded. The mean (SD) absolute difference and percentage difference between the 2 independent graders for each visit were 0.08 (0.10) mm2 and 4.5% (5.9%), respectively. The EZ area determined by the 2 graders showed excellent agreement with an intraclass correlation coefficient of 0.996 (95% CI, 0.995-0.997; P < .001). CONCLUSIONS AND RELEVANCE: Quantification of the preserved EZ area on en face SD-OCT images of patients with RP is a valid and reproducible method. En face SD-OCT quantification may be a useful tool for monitoring the EZ changes of patients with advanced RP and a useful outcome measurement variable in therapeutic trials.

Indexed as

AgedElectroretinographyFemaleGABA AgentsHumansMaleMiddle AgedObserver VariationReproducibility of ResultsRetinaRetinitis PigmentosaTomography, Optical CoherenceValproic AcidVisual AcuityVisual Field TestsGABA AgentsValproic Acid

Identifiers

PMID27031504
PMCPMC5317200
OpenAlexW2323875666

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.