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

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
leukocoria.

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.

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
Institute.

- 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.