An observational study in Retinopathy of Prematurity, sponsored by Siloam Vision. Completed at 1 site in United States. Open to participants aged 4 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Siloam Vision · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 51 studies in Retinopathy of Prematurity with a site in United States — 6 open to participants now, 10 under way, none of them phase 3. Retinopathy of Prematurity · United States.
Among the 51 studies in Retinopathy of Prematurity with a site in United States, this one is the 11th largest by enrollment of the 15 observational ones that give a count, is one of 3 that started in 2026, is one of 15 observational ones, and was the 51st registered.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
Browse Retinopathy of Prematurity studies →6 of the 51 studies in Retinopathy of Prematurity with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
FELIQS INC. · Sites in United States
Ages 4 days–5 days
Vanderbilt University Medical Center · Sites in United States
Ages 24 wk–34 wk
Duke University · Sites in United States
Ages up to 2 mo
Duke University · Sites in United States
Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 19 Retinopathy of Prematurity studies recruiting now, 7 (37%) set no upper age limit and 12 (63%) stop at 75 or younger; 19 take children under 18; 4 take healthy volunteers.
This study: 4 Weeks and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 11 · Phase 4 1
First in 1986; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.
Median enrollment 114 across the 32 interventional studies, 102 across the 15 observational. Of the 35 that completed or were terminated, 14 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 51 have an industry lead sponsor. The 10 most frequent:
Siloam Vision is the lead sponsor of 3 studies on the registry; none are open to participants now.
Siloam Vision has 3 studies filed under Retinopathy of Prematurity — fewer than ten, so there is no comparison to draw.
3 of the studies in Retinopathy of Prematurity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07093255FELIQS INC.Safety, PK and PD of FLQ-101 in Premature Neonates | 2026-12-31 |
| NCT04995341Duke UniversityRetinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) | 2027-03-31 |
| NCT05558059Duke UniversityImaging Retinal Vasculature in Infant Eyes | 2027-08-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 51 studies in Retinopathy of Prematurity with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a prospective, non-significant-risk clinical study sponsored by Siloam Vision, Inc. to evaluate whether ophthalmologists can assess retinopathy of prematurity (ROP) using images from the iCam-OCT device as effectively as with the current standard, binocular indirect ophthalmoscopy (BIO). Results will support an FDA 510(k) submission. A separate follow-up study (undilated OCT imaging, with dilation only before the BIO exam) is planned once this study completes.
Device. The iCam-OCT is a handheld, swept-source OCT (SS-OCT) system operating at 1040nm and 400kHz, with 7-micron depth resolution and a 12mm scan depth. It captures an ultra-widefield (197°) field of view - the widest reported for OCT - in a contact-based, non-mydriatic mode, with scans under one second and a full bilateral exam averaging 1-2 minutes. It's designed for supine imaging of infants/small children who can't use conventional tabletop OCT. It's a Class 1 laser product conforming to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, and ANSI Z80.36-2021. Over a dozen prior publications using earlier iCam-OCT prototypes (500+ patients, 1700+ imaging sessions) reported no adverse events and found the images clinically useful for ROP staging, zone assessment, and detection of related pathologies.
Sites and population. Two sites: Oregon Health \& Science University (Doernbecher NICU) and Children's Hospital Colorado Anschutz. Both sites are new to the device and unaffiliated with the sponsor. Enrollment target is a minimum of 40 premature infants meeting AAP ROP-screening criteria (birth weight \<1500g or gestational age ≤30 weeks; or birth weight 1500-2000g or gestational age >30 weeks if deemed at-risk). At least 30 infants must have ROP (stage 1 or worse in any zone) and at least 10 without ROP, with at least 20 subjects per site. Main exclusions are inability to obtain parental consent or clinical instability precluding research imaging.
Study design. After informed consent, each infant undergoes both a BIO exam (by an independent, ROP-experienced ophthalmologist unaffiliated with the sponsor) and iCam-OCT imaging, in randomized order, following pupil dilation per routine care. Imaging is performed by a trained/certified operator (ophthalmologist, nurse, technician, or coordinator) using a standardized protocol with up to six suggested scan views (posterior, temporal, nasal, temporal/nasal ora serrata, posterior HD). Anonymized OCT images are then graded independently by three masked, ROP-experienced ophthalmologists for image quality (0-3 scale) and clinical utility (usefulness for confirming normal structures or detecting pathology), and separately for ROP zone/stage/plus disease, without knowledge of the BIO findings.
Endpoints and performance goals.
Primary: percent of OCT image sets graded acceptable (score ≥2) for both quality and clinical utility - goal ≥85%.
Secondary: sensitivity/specificity of OCT-based ROP detection vs. BIO (goals >90% sensitivity, >70% specificity); documentation/visualization of full retinal vascularization to the ora serrata (same goals); and documentation of the vascular/avascular border in eyes with incomplete vascularization (same goals).
Safety: tracking of systemic AEs (nurse-initiated pauses), ocular AEs (corneal abrasion, conjunctival irritation, infection, need for topical medication), and any other AEs.
Discordant cases - infants classified "no ROP" by BIO but flagged as stage 1+ by OCT (potential false positives relative to the BIO gold standard) - get extra scrutiny: a coordinator reviews subsequent hospital records for later-diagnosed ROP, and all three graders reconvene to reach consensus on whether the OCT findings represent true early-stage ROP that BIO missed, versus immature retina with a defined vascular border. Clinical management throughout the study is driven by BIO only, not by OCT findings.
Statistics. The eye is the unit of analysis; each eye is graded independently by all three masked graders, and sensitivity/specificity are computed per grader and averaged. Sample size (n=30 for the ROP-positive group) was powered via a non-inferiority test assuming 85% BIO sensitivity (from a cited 2018 Biten et al. study), a 5% non-inferiority margin, and one-sided alpha of 0.05, yielding \~80% power. Supportive analyses include per-grader McNemar's tests for OCT/BIO discordance and non-inferiority testing of OCT sensitivity against the fixed 85% literature benchmark (not a within-study BIO comparison).
Safety monitoring. Risks are characterized as low (corneal abrasion, subconjunctival hemorrhage, infection - similar to standard contact ROP exams) plus general risks of apnea/bradycardia inherent to examining fragile premature infants. Dr. Benjamin Young serves as the independent safety monitor overseeing adverse event review; AEs/SAEs must be reported to the IRB within 5 days.
The study population is premature infants indicated for ROP screening - approximately 40 such infants will be enrolled in total, matching AAP screening guidelines (birth weight \<1500g or gestational age ≤30 weeks; or birth weight 1500-2000g or gestational age >30 weeks if judged at-risk by the attending pediatrician or neonatologist).
Inclusion Criteria:The patient must be an infant matching American Academy of Pediatrics (AAP) screening criteria for ROP evaluation, defined as one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study participants are premature infants who meet the American Academy of Pediatrics (AAP) screening criteria for ROP evaluation. Specifically, eligible infants must have either a birth weight under 1500g or a gestational age of 30 weeks or less, or, alternatively, a birth weight between 1500-2000g or a gestational age over 30 weeks if their attending pediatrician or neonatologist believes they're at risk for ROP.
Device: imaged with i-Cam OCT
enrolled infant undergoes both a BIO exam and iCam-OCT imaging (order randomized) during the same dilated eye exam
Clinical Quality
The primary outcome measure is the clinical quality and utility of iCam-OCT images, as judged by three independent, masked, ROP-experienced ophthalmologist graders.
Time frame: study visit - day 1
Presence or absence of ROP
Agreement between OCT image grading and BIO exam findings on whether ROP is present, defined as stage 1 or worse in any zone, with or without pre-plus or plus disease. Measured as sensitivity (target \>90%) and specificity (target \>70%), with BIO as the reference standard.
Time frame: study visit - day 1
Full vascularization documentation
In eyes that BIO determines to be fully vascularized, whether OCT can similarly document full retinal vascularization - specifically, visualization out to zone III and within two disc diameters of the ora serrata. Measured as sensitivity (target \>90%) and specificity (target \>70%); this assessment requires visualization of the ora serrata on the OCT images.
Time frame: study visit - day 1
Vascular/avascular border documentation
In eyes with incomplete retinal vascularization (areas of avascular retina) per BIO, whether OCT can document the vascular/avascular border. Again measured as sensitivity (target \>90%) and specificity (target \>70%). Visibility of the ora serrata is not required for this particular assessment.
Time frame: study visit - day 1
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — There is a plan to make IPD and related data dictionaries available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Ran from Jan 2026 to primary completion in Jul 2026, 5 months.
Of 25 observational studies under Retinopathy of Prematurity, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Siloam Vision