This project will establish an independent, investigator-initiated, multicenter randomized clinical trial investigating the clinical effectiveness, safety, and economic implications of topical ketorolac and nepafenac for preventing progression of early-stage ROP.
The trial will build upon microscopIA's retrospective multicenter clinical research and economic evaluation, moving from observational evidence to a prospective controlled study.
The proposed trial will compare topical ketorolac plus standard surveillance, topical nepafenac plus standard surveillance, and standard surveillance alone. The final study design, allocation procedures, masking, intervention regimens, and monitoring schedule will be established before ethics and regulatory submission.
Five selected researchers will participate in the development, coordination, and execution of the clinical trial.
Their responsibilities will include:
Clinical trial design: Develop the research protocol, intervention framework, eligibility criteria, outcome definitions, statistical analysis plan, case-report forms, data dictionary, and standardized operating procedures.
Ethics and regulatory submissions: Prepare documentation for the designated Ethics Committee and applicable Colombian regulatory authorities, respond to review queries, and maintain approved protocol versions.
Trial registration: Prepare and manage prospective registration on ClinicalTrials.gov before the first participant is enrolled.
National investigator recruitment: Identify Colombian ophthalmologists trained in ROP, assess their eligibility, and recruit pediatric ophthalmologists and retina and vitreous specialists capable of participating in the trial.
Institutional feasibility: Evaluate prospective sites according to neonatal patient volume, ophthalmologic capacity, longitudinal follow-up, treatment availability, research infrastructure, and applicable regulatory requirements.
Clinician training: Develop and deliver standardized training covering trial methodology, patient eligibility, randomization, outcome definitions, protocol adherence, documentation, adverse-event reporting, and data collection.
Independent fundraising: Work with microscopIA to identify research grants, philanthropic donors, institutional partners, and other appropriate independent funding sources, prepare funding proposals, and support financial planning.
Trial logistics: Coordinate site onboarding, investigator meetings, study documentation, research supplies, data-management infrastructure, and communication between participating institutions.
Prospective data collection: Support clinicians during recruitment, informed consent, patient follow-up, clinical documentation, and protocol-authorized parent or guardian contact.
Quality control and safety: Monitor data completeness, resolve inconsistencies, document protocol deviations, and support safety reporting and independent trial oversight.
Statistical and economic analysis: Participate in database cleaning, clinical outcome analysis, healthcare resource-utilization analysis, and economic evaluation under Jorge Racedo's supervision.
Scientific dissemination: Contribute to manuscript drafting, critical revision, conference abstract preparation, scientific poster development, and responses to journal reviewers.
Clinical treatment decisions and retinal outcome adjudication will remain under appropriately qualified clinicians.
The project is expected to generate a complete clinical trial protocol and an operational framework for independent multicenter research in Colombia.
The principal deliverables are:
Clinical trial development
An ethics-ready protocol, statistical analysis plan, standardized operating procedures, investigator manual, informed-consent documents, case-report forms, data dictionary, randomization framework, and independent safety-monitoring plan.
National investigator network
A verified database of Colombian ROP-trained ophthalmologists, site-feasibility assessments, documented investigator commitments, standardized clinician training materials, and an operational multicenter collaboration framework.
Ethics, regulatory, and registration
Institutional and Ethics Committee submission packages, applicable regulatory documentation, and prospective ClinicalTrials.gov registration.
Independent funding
A documented trial budget, fundraising strategy, grant applications, philanthropic funding proposals, and financial oversight arrangements designed to preserve scientific independence.
Trial execution
Subject to approval and adequate funding, an activated clinical investigator network, prospective participant recruitment, standardized ophthalmologic follow-up, safety reporting, trial-monitoring records, and a quality-controlled multicenter database.
Scientific outputs
A clinical effectiveness and safety analysis, a prospective economic evaluation, a manuscript intended for submission to a peer-reviewed, PubMed-indexed journal, and a scientific poster prepared for an international conference.
Professional recognition
Every selected researcher completing documented project responsibilities will receive an individualized microscopIA clinical research certificate.
All five participants will have defined scientific responsibilities designed to enable them to qualify for authorship when the applicable international authorship criteria are fulfilled.
One participant may be selected to present the resulting scientific poster at an international conference, subject to abstract acceptance and confirmed logistical arrangements.
The October 2026 to April 2027 period is the target for project establishment and initial execution. Recruitment completion, final patient follow-up, database lock, and publication may extend beyond April if required.
Clinical Trial
Ophthalmology, Pediatrics, Clinical Epidemiology, Neonatology, Health Economics
Jorge Racedo at microscopIA, External Clinicians
Applicants may include physicians, medical students, biomedical or health researchers, epidemiologists, and other candidates with a relevant clinical or research background.
Applicants must:
Be fluent in Spanish.
Have documented training or formal coursework in biostatistics.
Be able to contribute to statistical analysis under Jorge Racedo's supervision.
Have strong attention to research documentation and participant confidentiality.
Be available during the protocol-development phase and the prospective data-collection period.
Be able to collaborate with pediatric ophthalmology and retina specialists.
Have reliable internet access for remote project activities.
Availability for approximately 3–5 hours per week.
Experience in neonatology, pediatrics, ophthalmology, clinical epidemiology, nutrition, or clinical trials is desirable.
Any Country
Protocol Development, Ethics Submission, Trial Registration, Informed Consent, Parent Follow-Up, Clinical Data Collection, Data Curation, Data Validation, Data Quality Control, Biostatistical Analysis, Literature Review, Manuscript Preparation, Manuscript Revision, Conference Presentation, Poster Preparation, Response to Reviewers, Data Collection Data Curation Data Validation Data Quality Control Literature Review Database Development Manuscript Preparation Manuscript Revision Conference Presentation Poster Preparation Response to Reviewers, Clinical Trial Design Protocol Development Ethics Submission Regulatory Submission Trial Registration Investigator Recruitment Site Feasibility Assessment Clinician Training Independent Fundraising Trial Coordination Safety Monitoring Statistical Analysis Health Economic Evaluation
5
Spanish, English
microscopIA conducted a multicenter retrospective study involving 192 premature infants across 14 Colombian healthcare institutions, investigating topical ketorolac and nepafenac for early-stage Retinopathy of Prematurity (ROP). Progression to treatment-requiring disease occurred in 20.83% of infants receiving ketorolac and 22.45% receiving nepafenac, compared with 45.65% in the historical surveillance group. Both medications were associated with faster disease regression and fewer ophthalmologic follow-up visits. After statistical adjustment, ketorolac remained significantly associated with reduced progression, with an adjusted odds ratio of 0.28. No major prophylaxis-related adverse events were reported.
Building on these findings, microscopIA conducted an economic evaluation from the Colombian healthcare-system perspective. Mean ROP-attributable costs were USD 430.30 for ketorolac, USD 436.60 for nepafenac, and USD 878.11 for standard surveillance, although the cost differences were not statistically significant (likely associated with highly distributed values) yet economically compelling. Ketorolac was associated with a statistically significant increase in quality-adjusted life-years compared with surveillance, 0.49 versus 0.46. Probabilistic analyses estimated cost-effectiveness probabilities of 71.90% for ketorolac and 68.16% for nepafenac at Colombia's willingness-to-pay threshold of USD 5,180.80 per quality-adjusted life-year. The estimated net monetary benefits were USD 598.18 and USD 484.14, respectively.
Together, these studies provide the clinical and economic rationale for microscopIA's proposed independent multicenter randomized clinical trial. Although the retrospective findings suggest potential benefits, the use of historical controls and the limitations of observational research prevent causal conclusions. The new trial will prospectively evaluate clinical effectiveness, ocular and systemic safety, and economic outcomes to determine whether either medication offers a clinically meaningful and economically sustainable strategy for preventing progression to treatment-requiring ROP.
A more recent large observational analysis also reported differences in treated retinopathy between exclusive human-milk and formula-supplemented groups while emphasizing residual confounding and the need for randomized evidence.
The protocol should follow Standard Protocol Items: Recommendations for Interventional Trials 2025 and the final report should follow Consolidated Standards of Reporting Trials 2025 if the approved design is randomized.
Record from a Project with a Foundational Methodology
Human milk intake and retinopathy of prematurity in extremely low birth weight infants. PMID: 17606555.microscopIA will provide structured methodological training and ongoing scientific supervision throughout the project.
Training will cover clinical trial design, development of randomized protocols, sample-size calculation, statistical analysis planning, ethics and regulatory submissions, Good Clinical Practice, trial registration, investigator recruitment, institutional feasibility, informed consent, data management, trial monitoring, safety documentation, economic evaluation, fundraising, and scientific publication.
Jorge Racedo will supervise the methodological, statistical, and economic components.
Participating ROP specialists will supervise clinical eligibility, disease staging, ophthalmologic outcome assessment, safety evaluation, and clinical treatment decisions.
Participants will receive training materials, standardized documentation, investigator meeting support, and access to approved research communication and data-management systems.
September 28, 2026 at 12:00:00 AM
September 30, 2026
October 1, 2026
April 30, 2027
Each participant may report a maximum of two legitimate institutional affiliations.
Required format:
Department, Institution or Organization, City, CountrymicroscopIA will cover approved publication fees associated with the anticipated regional manuscript.
Participants will not be required to personally pay approved article-processing charges.
Memberships are reinvested to pay microscopIA staff (epidemiologists, engineers, data scientists) salaries and to cover the publication fees for the resulting manuscripts. This maintain our work neutral, financially self-sustainable, and without any existing conflict of interest to maintain rigor and integrity in evidence generation.