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Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
NCT00000133 · View on ClinicalTrials.gov ↗
Study Summary
To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness from ROP. To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and without cryotherapy.
Conditions Studied
Interventions
- PROCEDURE Trans-scleral Cryotherapy
Study Locations (20)
District of Columbia
- Private practice of David Plotsky, MD — Washington D.C.
- Retina Group of Washington — Washington D.C.
Michigan
- Private practice of John D. Baker, MD — Dearborn
- Associated Retinal Consultants, P.C. — Royal Oak
Ohio
- Private Practice of Miles J. Burke, MD — Cincinnati
- Columbus Children's Hospital — Columbus
Pennsylvania
- Children's Hospital of Philadelphia, Division of Pediatric Ophthalmology — Philadelphia
- Pediatric Ophthalmology and Strabismus, Inc. — Pittsburgh
Alabama
- Alabama Ophthalmology Associates, P.C. — Birmingham
Florida
- Bascom Palmer Eye Institute, University of Miami School of Medicine — Miami
Illinois
- University of Illinois Eye and Ear Infirmary — Chicago
Indiana
- Department of Ophthalmology, Indiana University School of Medicine — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Start Date | 1986-01 |
| Est. Completion | 2003-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000133
The ClinicalTrials.gov registry entry for NCT00000133 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Eye Institute (NEI), which has 214 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Retinopathy of Prematurity appearing as the primary indexed condition, and to 1 intervention — of which Trans-scleral Cryotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00000133 reports 20 study locations spanning 16 distinct geographic areas — top geographies include District of Columbia, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00000133 about?
NCT00000133 is a clinical study titled "Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity". To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness from ROP. To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and without ...
What is the current status of trial NCT00000133?
This trial is currently completed. It is a NA study. The study started on 1986-01. Estimated completion is 2003-08.
What conditions does trial NCT00000133 study?
This clinical trial studies the following conditions: Retinopathy of Prematurity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00000133?
The interventions under investigation include: Trans-scleral Cryotherapy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00000133?
This trial is sponsored by National Eye Institute (NEI), which has 214 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00000133 being conducted?
This trial has 20 study locations across Alabama, District of Columbia, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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