ExotropiaDESDEENCT05242510
Evaluation of Exotropia After Patching the Eye or After Prism Adaptation
A study testing Patching and Prism Adaptation in people with Exotropia, run by University of Rochester at 9 sites in 5 countries.
Trial summary
This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Exotropia
- What is being tested?
- Patching and Prism Adaptation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 27 Aug 2024to 18 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
- No prior strabismus surgery
- Able to cooperate with testing (by examiner determination)
- Neurologically normal except for strabismus (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
- Not amblyopic at the time of enrollment (best-corrected visual acuity in both eyes of 20/40 or better)
- Under 18 years of age. There is no lower age limit as long as the subject can cooperate for the required testing.
- No diagnosis of dissociated vertical deviation
Who cannot join
- No diagnosis of divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
- Prior strabismus surgery
- Unable to cooperate with testing (by examiner determination)
- Diagnosed with a neurological disorder (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
- Best-corrected visual acuity in either eye worse than 20/40
- 18 years of age or older
- Diagnosed with dissociated vertical deviation
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United States5 sites
Harvard University
Boston, Massachusetts, 02115
Ross Eye Institute
Buffalo, New York, 14209
University of California Los Angeles
Los Angeles, California, 90095
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Divergence Excess/Simulated Divergence Excess Exotropia (DESDEE)
This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.
- Conditions
- Exotropia
- Being tested
- Patching, Prism Adaptation
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatchingProcedure or surgery
The subject will occlude the non-dominant eye for 24 hours.
Prism AdaptationProcedure or surgery
The subject will undergo prism adaptation targeting the pre-occlusion distance angle for 1-2 weeks. • Fresnel prism(s) will be applied to the patient's spectacles equaling the distance angle between the two eyes. At the examiner's discretion depending on the size of the deviation, the prism(s) can be placed solely over the non-dominant eye, or split between the 2 eyes in some combination which results in equalization of the distance exotropia. If the distance angle calls for an amount of prism that cannot be exactly replicated with Fresnel prisms (e.g., 32 PD), the amount of prism used will be determined by rounding down to the nearest practical amount at examiner discretion.
| Study group | Role | What they receive |
|---|---|---|
| Patching | Experimental | Not described Receives: Procedure: Patching |
| Prism Adaptation | Experimental | Not described Receives: Procedure: Prism Adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants reclassified as divergence excess exotropia
Percentage of patients with distance and near exotropia measurements within 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Measured: 2 weeks
Percent of participants reclassified as simulated divergence excess exotropia
Percentage of patients with distance and near exotropia measurements differing by more than 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start27 Aug 2024
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Why it stopped: lack of ability to enroll from other sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Gearinger, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242510
- Sponsor's protocol ID
- STUDY00006849
- Acronym
- DESDEE
- Status last verified
- Apr 2025
- First submitted
- 24 Jan 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Divergence Excess/Simulated Divergence Excess Exotropia (DESDEE)
- ClinicalTrials.gov ID
- NCT05242510
- Acronym / sponsor ID
- DESDEE / STUDY00006849
- Conditions
- Exotropia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of ability to enroll from other sites
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patching | Experimental | Procedure: Patching |
| Prism Adaptation | Experimental | Procedure: Prism Adaptation |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosed with divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
- No prior strabismus surgery
- Able to cooperate with testing (by examiner determination)
- Neurologically normal except for strabismus (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
- Not amblyopic at the time of enrollment (best-corrected visual acuity in both eyes of 20/40 or better)
Key exclusion criteria (7 listed)
- No diagnosis of divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
- Prior strabismus surgery
- Unable to cooperate with testing (by examiner determination)
- Diagnosed with a neurological disorder (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
- Best-corrected visual acuity in either eye worse than 20/40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatchingThe subject will occlude the non-dominant eye for 24 hours. | Procedure or surgery | Patching |
| Prism AdaptationThe subject will undergo prism adaptation targeting the pre-occlusion distance angle for 1-2 weeks. • Fresnel prism(s) will be applied to the patient's spectacles equaling the distance angle between the two eyes. At the examiner's discretion depending on the size of the deviation, the prism(s) can be placed solely over the non-dominant eye, or split between the 2 eyes in some combination which results in equalization of the distance exotropia. If the distance angle calls for an amount of prism that cannot be exactly replicated with Fresnel prisms (e.g., 32 PD), the amount of prism used will be determined by rounding down to the nearest practical amount at examiner discretion. | Procedure or surgery | Prism Adaptation |
Primary outcome
Percent of participants reclassified as divergence excess exotropia
Time frame: 2 weeks
Percentage of patients with distance and near exotropia measurements within 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Percent of participants reclassified as simulated divergence excess exotropia
Time frame: 2 weeks
Percentage of patients with distance and near exotropia measurements differing by more than 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Results and safety
The study was stopped early (reason given: lack of ability to enroll from other sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patching and Prism Adaptation in people with Exotropia, run by University of Rochester at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, India, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of ability to enroll from other sites). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants reclassified as divergence excess exotropia (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.