StudyFinder
Search Results Within Category "Ophthalmology/Eyes"
6 Study Matches
RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
Megan Megan Quinlan-Waters - Megan.Quinlan-Waters@cchmc.org
ALL
1 year to 16 years old
NCT06273748
Inclusion Criteria:
* diagnosis of non-infectious chronic uveitis before the age of 16;
* signed informed consent form.
Exclusion Criteria:
* Patients with a diagnosis of infectious uveitis
* history of malignant pathology,
* history of demyelinating pathology,
* history of cerebral vasculitis Uveitis
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age (ATS24)
Jillian Bulman - jillian.bulman@cchmc.org
ALL
8 years to 12 years old
PHASE3
NCT06524882
Inclusion Criteria:
• Age 8 to \<13 years.
• VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
• VA in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters with E-ETDRS).
• VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS).
• Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
• Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation. * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
• Criteria for anisometropia: At least one of the following criteria must be met: * ≥1.00 D difference between eyes in spherical equivalent (SE). * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• Criteria for combined-mechanism: Both of the following criteria must be met: * A criterion for strabismus is met (see above). * ≥1.00 D difference between eyes in SE OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• No more than 2 weeks (cumulative) of prior dichoptic treatment
• No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
• Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: * Hypermetropia of 2.50 D or more by SE * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below. NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
• Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). * SE must not be under corrected by more than 1.50D SE. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
• Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: * For at least 18 weeks OR until VA stability is documented (defined as \<1-line change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.
• Participant is willing to wear a headset.
• Participant is willing to continue full-time spectacles/contact lens wear (if needed).
• Interpupillary distance of 52mm to 72mm inclusive.
• Investigator is willing to prescribe continued spectacles/contact lens correction (if needed) or either dichoptic device per protocol.
• Participant is willing to accept assignment to either continued spectacles/ contact lens wear alone, dichoptic movies/shows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks.
• Parent understands the protocol and is willing to accept randomization.
• Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff.
• Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.
Exclusion Criteria:
• Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
• Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.
• Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
• Myopia greater than -6.00D spherical equivalent in either eye.
• Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
• Diplopia more than once per week over the last week prior to enrollment by parental report.
• History of light-induced seizures.
• Known simulator sickness.
• Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
• Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.
DEVICE: Vivid Vision, DEVICE: Luminopia, DEVICE: Optical Correction
Amblyopia
Dichoptic, Luminopia, Vivid Vision, Game, movie, glasses
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching (ATS22)
Shipra Rai - shipra.rai2@cchmc.org
ALL
3 years to 13 years old
PHASE3
NCT04378790
Inclusion Criteria:
• Age 3 to \<13 years at the time of randomization
• Amblyopia associated with anisometropia, strabismus, or both o Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with or without optical correction) * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia) * Criteria for anisometropia: At least one of the following criteria must be met: * 1.00 D difference between eyes in spherical equivalent (SE) * 1.50 D difference in astigmatism between corresponding meridians in the two eyes * Criteria for combined-mechanism amblyopia: Both of the following criteria must be met: * Criteria for strabismus are met (see above) * 1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
• No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
• Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:
• Full correction of anisometropia
• Full correction of astigmatism with the same axis found by the cycloplegic refraction
• Full correction of any myopia
• Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
• At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows: * VA in the amblyopic eye 20/40 to 20/200 inclusive. * Age-normal VA in the fellow eye:40,41 * 3 years: 0.4 logMAR (20/50) or better * 4 years: 0.3 logMAR (20/40) or better * 5-6 years: 0.2 logMAR (20/32) or better * 7-12 years: 0.12 logMAR (78 letters) or better * Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).
• Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
• Parent understands the protocol and is willing to accept randomization.
• Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
• Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.
Exclusion Criteria:
• Myopia greater than -6.00 D spherical equivalent in either eye.
• Previous intraocular or refractive surgery.
• Planned strabismus surgery in the next 56 weeks.
• Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
• Previous spectacle or contact lens wear for more than 24 hours.
• Parent and participant willing to forego option of contact lens wear for the duration of the study.
• Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).
• Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or attention deficit hyperactivity disorder (ADHD) are not excluded.
• Known allergy to adhesive patches.
• Known allergy to silicone.
OTHER: Patching, OTHER: Glasses
Amblyopia
patching, glasses, spectacles, simultaneous, sequential
A Study of Uveitis in Children <18 Years of Age (UV1)
Shipra Rai - shipra.rai2@cchmc.org
ALL
Up to 17 years old
NCT07518134
Inclusion Criteria:
* Age:
* Incident cases (onset ≤ 6 months) \<17 years
* Established cases (onset \> 6 months) \<18 years
* Diagnosis of any type of uveitis (infectious or noninfectious) in any location except traumatic and post-operative uveitis.
* Active or inactive uveitis with any treatment status (current / prior / none \[but under surveillance\]).
Exclusion Criteria:
* Bilateral uveitis with differing etiologies
* Traumatic uveitis
* Post-operative uveitis
* Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of JAEB Center for Health Research.
* Ocular disease related to Retinoblastoma, Coat's disease, retinitis pigmentosa, inherited retinal degeneration, Juvenile xanthogranuloma (JXG), or leukemia/malignancy within the eye. Uveitis
pediatric, uveitis
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)
Jillian Bulman - jillian.bulman@cchmc.org
ALL
4 years to 7 years old
PHASE3
NCT06380517
At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.
• Age 4 to 7 years.
• Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
• VA in the amblyopic eye 20/40 to 20/200 inclusive.
• Age-normal VA in the fellow eye:44,45 • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better
• Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
• Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below). * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
• Criteria for anisometropia: At least one of the following criteria must be met: * ≥1.00 D difference between eyes in spherical equivalent (SE). * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• Criteria for combined-mechanism: Both of the following criteria must be met: * A criterion for strabismus is met (see above). * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• No more than 2 weeks (cumulative) of prior dichoptic treatment.
• No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
• Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: * Hypermetropia of 2.50 D or more by SE * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
• Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). * SE must not be under corrected by more than 1.50D SE. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
• Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: * For at least 18 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.
• Participant is willing to wear the Luminopia headset.
• Participant is willing to continue full-time spectacles/contact lens wear (if needed).
• Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.
• Interpupillary distance of 52mm to 72mm inclusive.
• Investigator is willing to prescribe Luminopia or patching per protocol.
• Parent understands the protocol and is willing to accept randomization.
• Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.
• Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated. Individuals meeting any of the following criteria will be excluded from study participation.
• Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
• Prism lenses or need of a prism prescription at enrollment.
• Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
• Myopia greater than -6.00D spherical equivalent in either eye.
• Previous intraocular or refractive surgery.
• Known skin reactions to patch or bandage adhesives.
• Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
• Diplopia more than once per week over the last week prior to enrollment by parental report.
• History of light-induced seizures.
• Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
• Participation in a prior study involving patching for amblyopia
• Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.
• Age 4 to 7 years.
• Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
• VA in the amblyopic eye 20/40 to 20/200 inclusive.
• Age-normal VA in the fellow eye:44,45 • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better
• Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
• Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below). * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
• Criteria for anisometropia: At least one of the following criteria must be met: * ≥1.00 D difference between eyes in spherical equivalent (SE). * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• Criteria for combined-mechanism: Both of the following criteria must be met: * A criterion for strabismus is met (see above). * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• No more than 2 weeks (cumulative) of prior dichoptic treatment.
• No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
• Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: * Hypermetropia of 2.50 D or more by SE * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
• Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). * SE must not be under corrected by more than 1.50D SE. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
• Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: * For at least 18 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.
• Participant is willing to wear the Luminopia headset.
• Participant is willing to continue full-time spectacles/contact lens wear (if needed).
• Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.
• Interpupillary distance of 52mm to 72mm inclusive.
• Investigator is willing to prescribe Luminopia or patching per protocol.
• Parent understands the protocol and is willing to accept randomization.
• Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.
• Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated. Individuals meeting any of the following criteria will be excluded from study participation.
• Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
• Prism lenses or need of a prism prescription at enrollment.
• Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
• Myopia greater than -6.00D spherical equivalent in either eye.
• Previous intraocular or refractive surgery.
• Known skin reactions to patch or bandage adhesives.
• Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
• Diplopia more than once per week over the last week prior to enrollment by parental report.
• History of light-induced seizures.
• Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
• Participation in a prior study involving patching for amblyopia
• Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.
DEVICE: Luminopia, OTHER: Eye Patch
Amblyopia
Dichoptic, Luminopia, Patching, movie
Studying Health Outcomes After Treatment in Patients With Retinoblastoma (RIVERBOAT)
Amanda Pfeiffer - amanda.pfeiffer@cchmc.org
ALL
NCT03932786
* Unilateral or bilateral intraocular retinoblastoma
* Diagnosis between the ages of 0 - 17.99 years
* Diagnosis on or after January 1, 2008
* No exclusions based on primary or secondary treatment modalities
* Retrospective group patients must be ≥ 6 months post end of treatment at study entry
* For those already at this timepoint, they are now eligible
* For those in treatment, or otherwise not yet at this timepoint, they are eligible once at they are ≥ 6 months post end of treatment
* Prospective group patients must not have begun treatment
* Patients with diminished capacity will not be enrolled.
* Language: Patients must be able to communicate in English, French, or Spanish
* Sibling Cohort: One sibling, not affected by retinoblastoma will be enrolled, preference for the sibling closest in age to the RB patient.
* Regulatory Requirements: All patients and/or their parents or legal guardians must sign a written informed consent. All institutional, FDA, and NCI requirements for human studies must be met.
PROCEDURE: Biospecimen collection, OTHER: Vision assessment, OTHER: Questionnaire administration, OTHER: Quality of life assessment, OTHER: Laboratory Biomarker Analysis
Retinoblastoma, Cancer Survivor, Biological Sibling, Intraocular Retinoblastoma, Unilateral Retinoblastoma