Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma

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Brief Title

Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma

Official Title

Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma

Brief Summary

      This study seeks to determine whether a smartphone application called CRADLE (ComputeR
      Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria.
      There will be no impact on participants' health outcome.

      This study will be performed in two parts, each with a distinct cohort of patients.

      Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within
      patients known to have leukocoria.

      Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using
      the techniques selected from information gathered in Part 1) as compared to an
      ophthalmoscope, within patients referred to the clinic for suspected leukocoria.


        -  To determine the most effective usage of a camera phone application (CRADLE) to maximize
           detection of leukocoria in patients with retinoblastoma, congenital cataracts, and

        -  To estimate the sensitivity and specificity of a camera phone application (CRADLE) in
           detecting leukocoria.

Detailed Description

      This study will utilize three strata called Stratum I, Stratum II and Stratum III.

      STRATUM I - Infants and children known to have leukocoria who have been diagnosed with
      retinoblastoma, cataracts or glaucoma or other eye conditions.

      Participants enrolled on Stratum I of the study will have the CRADLE application used by the
      doctor during their appointment.

      The participant will look straight forward while the doctor stands about 1-3 feet away
      holding the device that has the CRADLE application. He or she will slowly move the device up,
      down, middle, right, and left - both in a lit and dimmed room.

      The participant will be videotaped and photographed during this appointment. The doctor will
      record the results as determined by CRADLE ("normal" or no leukocoria versus "abnormal" or
      positive for leukocoria).

      STRATUM II - Infants and children who are referred to an eye doctor to evaluate for

      Participants enrolled on Stratum II of the study will be asked to look straight forward while
      he or she uses the CRADLE application (using the best method determined from Stratum I). The
      doctor will also examine the participant's eyes with the ophthalmoscope method. The results
      from both CRADLE and the ophthalmoscope method will be recorded and compared (white eye
      present versus absent, and normal versus abnormal as described above).

      STRATUM III - Infants and children receiving treatment for retinoblastoma. For participants
      enrolled on Stratum III, he or she will have the same procedures as described in Stratum II.

      After receiving informed consent, participants will undergo evaluation by ophthalmoscope and
      CRADLE on Day 1. Stratum III participants only will also undergo CRADLE evaluation on Days 2,
      3, and 4.

Study Type


Primary Outcome

Rate of detection of leukocoria using CRADLE





Study Arms / Comparison Groups

 Stratum I: Initial Evaluation Group
Description:  Initially, a small group of patients diagnosed with congenital or infantile cataracts, congenital glaucoma or retinoblastoma and who meet the eligibility criteria will undergo testing with CRADLE on Day 1.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

March 15, 2018

Completion Date

June 30, 2023

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria - Stratum I:

          -  Patient has been diagnosed with congenital or infantile cataracts, congenital
             glaucoma, or retinoblastoma, and is scheduled for a visit with an ophthalmologist at
             St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye

          -  Patient with retinoblastoma is newly diagnosed, or has received < 2 cycles of
             chemoreductive therapy, and has not undergone enucleation.

          -  Patient with cataracts or glaucoma has not received any prior therapy.

        Inclusion Criteria - Stratum II:

          -  Patient without prior diagnosis has been referred for ophthalmological evaluation,
             including leukocoria or other conditions.

        Inclusion Criteria - Stratum III:

          -  Patient with retinoblastoma undergoing ocular salvage treatment.

        Exclusion Criteria

          -  Prior treatment for cataracts or glaucoma

          -  Inability or unwillingness of research participant or legal guardian to consent.




N/A - 7 Years

Accepts Healthy Volunteers



Carlos Rodriguez-Galindo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

St. Jude Children's Research Hospital

Study Sponsor

Carlos Rodriguez-Galindo, MD, Principal Investigator, St. Jude Children's Research Hospital

Verification Date

April 2022