Convergence InsufficiencySAS1NCT02510040
A Prospective Observational Study of Adult Strabismus
An observational study of Convergence Insufficiency and Divergence Insufficiency, run by Jaeb Center for Health Research at 1 site in United States.
Trial summary
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Convergence Insufficiency, Divergence Insufficiency, Hypertropia
- What is being tested?
- Prism, Orthoptic Exercises and Eye Muscle Surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2015to 31 Jan 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample
Who may be able to join
None listed.
Who cannot join
- The following criteria exclude a subject from enrollment into the study:
- No adult-onset DI (at ≥18 years of age)
- Prior strabismus surgery
- Distance esodeviation outside the range of 2∆ to 30∆ and less than 50% larger than at near by PACT
- More than 5∆ difference between right and left gaze by PACT
- More than 10∆ difference between the primary position at distance
Show all 33Show fewer
- Any coexisting vertical deviation more than distance esodeviation and ≥10∆ by PACT
- Visual acuity worse than 20/50 in either eye by ETDRS or Snellen
- Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
- Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
- Monocular diplopia
- Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease.
- Inferior or superior oblique overaction defined as 2+ or greater
- Inability to fuse with prism in space (see section 2.4.2)
- Inability to understand and complete a survey
- Treatment to be initiated has already been used within the past one year
- The following criteria exclude a subject from enrollment into the study:
- No adult-onset HT (at ≥18 years of age)
- Prior strabismus surgery
- Vertical deviation ≤1∆ or ≥10∆ at distance and near by PACT
- More than 4∆ difference from the primary in any gaze position by PACT
- Coexisting esodeviation must not be less than the vertical deviation
- Coexisting exodeviation ≥10∆ by PACT
- Convergence insufficiency as defined in section 2.2.1
- Visual acuity worse than 20/50 in either eye by ETDRS or Snellen
- Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
- Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
- Monocular diplopia
- Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease.
- Inferior or superior oblique overaction defined as 2+ or greater
- Inability to fuse with prism in space (see section 2.4.3)
- Inability to understand and complete a survey
- Treatment to be initiated has already been used within the past one year
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia.
Read the detailed description
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Treatment comparisons within the studied conditions will also be done to help develop future studies.
- Being tested
- Prism, Orthoptic Exercises, Eye Muscle Surgery, Botox Injection
- Keywords
- Convergence Insufficiency, Divergence Insufficiency, Small-angle Hypertropia, Strabismus
- Medical subject headings
- Ocular Motility Disorders, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrismDevice
Ground-in or Fresnel prism
Orthoptic ExercisesOther
Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy
Eye Muscle SurgeryProcedure or surgery
- Bilateral medial rectus muscle resection surgery
- Single medial rectus muscle resection surgery
- Recess lateral rectus muscle resection medial rectus muscle surgery
- Bilateral lateral rectus muscle recession surgery
- Single lateral rectus muscle recession surgery
- Bilateral lateral rectus muscle resection surgery
- Single lateral rectus muscle resection surgery
- Recess medial rectus muscle resection lateral rectus muscle surgery
- Bilateral medial rectus muscle recession surgery
- Single medial rectus muscle recession surgery
- Vertical rectus muscle recession surgery
- Vertical rectus muscle mini-tenotomy (snip) surgery
Botox InjectionProcedure or surgery
Also called Botulinum toxin injection
Botulinum toxin injection
| Study group | Role | What they receive |
|---|---|---|
| Convergence insufficiency | Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice. Receives: Device: Prism; Other: Orthoptic Exercises; Procedure: Eye Muscle Surgery; Procedure: Botox Injection | |
| Divergence insufficiency | Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice. Receives: Device: Prism; Other: Orthoptic Exercises; Procedure: Eye Muscle Surgery; Procedure: Botox Injection | |
| Small-angle hypertropia | Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice. Receives: Device: Prism; Other: Orthoptic Exercises; Procedure: Eye Muscle Surgery; Procedure: Botox Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Symptom Success at 10 Weeks
In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.
Measured: 10 weeks after enrollment
Number of Participants With Symptom Success at 12 Months
In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.
Measured: 12 months after enrollment
Secondary outcomes (5)
Mean of Near Point of Convergence in Convergence Insufficiency Group
Near point of convergence (convergence insufficiency group only).
Measured: 12 months after enrollment
Mean Positive Fusional Vergence in Convergence Insufficiency Group
Positive fusional vergence (convergence insufficiency group only).
Measured: 12 months after enrollment
Adult Strabismus 20 Questionnaire Score (DI)
Adult Strabismus Quality of Life Questionnaire (AS-20) For AS-20, scores are reported for the following subscales. A total score will not be reported.
- Self-perception score
- Interaction score
- Reading function score
- General function score Values for each subscale range from 0 to 100. 0 indicates poor quality of life (the patient reported "always" for all questions) and 100 represents good quality or life (patient reported "never" for all questions)
Measured: 12 months after enrollment
Mean Convergence Insufficiency Symptom Survey Score
Mean Convergence Insufficiency Symptom Survey Score (convergence insufficiency group only) For CISS, the range is from 0 (having no symptoms of CI) to 60 (always showing all symptoms of CI).
Measured: 12 months after enrollment
Adult Strabismus 20 Questionnaire Score (CI)
Adult Strabismus Quality of Life Questionnaire (AS-20) For AS-20, scores are reported for the following subscales. A total score will not be reported.
Self-perception score Interaction score Reading function score General function score Values for each subscale range from 0 to 100. 0 indicates poor quality of life (the patient reported "always" for all questions) and 100 represents good quality or life (patient reported "never" for all questions)
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study start17 Aug 2015
- Primary completion31 Dec 2017
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Convergence InsufficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Earl R Crouch, III, MD, Study chair, Virginia Pediatric Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510040
- Sponsor's protocol ID
- SAS1
- Other IDs
- 2U10EY011751
- Acronym
- SAS1
- Status last verified
- Jun 2023
- First submitted
- 24 Jul 2015
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Publications
Crouch ER, Dean TW, Kraker RT, Miller AM, Kraus CL, Gunton KB, Repka MX, Marsh JD, Del Monte MA, Luke PA, Peragallo JH, Lee KA, Wheeler MB, Daley TJ, Wallace DK, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group. A prospective study of treatments for adult-onset divergence insufficiency-type esotropia. J AAPOS. 2021 Aug;25(4):203.e1-203.e11. doi: 10.1016/j.jaapos.2021.02.014. Epub 2021 Jul 13.
PubMed 34271207Lorenzana IJ, Leske DA, Hatt SR, Dean TW, Jenewein EC, Dagi LR, Beal CJ, Pang Y, Retnasothie DV, Esposito CA, Erzurum SA, Aldrich AE, Crouch ER, Li Z, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group. Relationships among Clinical Factors and Patient-reported Outcome Measures in Adults with Convergence Insufficiency. Optom Vis Sci. 2022 Sep 1;99(9):692-701. doi: 10.1097/OPX.0000000000001929. Epub 2022 Aug 2.
PubMed 35914096
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Adult Strabismus
- ClinicalTrials.gov ID
- NCT02510040
- Acronym / sponsor ID
- SAS1 / SAS1
- Keywords
- Convergence Insufficiency, Divergence Insufficiency, Small-angle Hypertropia, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 17 Aug 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia.
Detailed description
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Treatment comparisons within the studied conditions will also be done to help develop future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Convergence insufficiency | – | Device: Prism, Other: Orthoptic Exercises, Procedure: Eye Muscle Surgery, Procedure: Botox InjectionEligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice. |
| Divergence insufficiency | – | Device: Prism, Other: Orthoptic Exercises, Procedure: Eye Muscle Surgery, Procedure: Botox InjectionEligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice. |
| Small-angle hypertropia | – | Device: Prism, Other: Orthoptic Exercises, Procedure: Eye Muscle Surgery, Procedure: Botox InjectionEligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (0 listed)
Key exclusion criteria (33 listed)
- No adult-onset DI (at ≥18 years of age)
- Prior strabismus surgery
- Distance esodeviation outside the range of 2∆ to 30∆ and less than 50% larger than at near by PACT
- More than 5∆ difference between right and left gaze by PACT
- More than 10∆ difference between the primary position at distance
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 |
|---|---|---|
| PrismGround-in or Fresnel prism | Device | Convergence insufficiency, Divergence insufficiency, Small-angle hypertropia |
| Orthoptic ExercisesOrthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy | Other | Convergence insufficiency, Divergence insufficiency, Small-angle hypertropia |
| Eye Muscle Surgery* Bilateral medial rectus muscle resection surgery * Single medial rectus muscle resection surgery * Recess lateral rectus muscle resection medial rectus muscle surgery * Bilateral lateral rectus muscle recession surgery * Single lateral rectus muscle recession surgery * Bilateral lateral rectus muscle resection surgery * Single lateral rectus muscle resection surgery * Recess medial rectus muscle resection lateral rectus muscle surgery * Bilateral medial rectus muscle recession surgery * Single medial rectus muscle recession surgery * Vertical rectus muscle recession surgery * Vertical rectus muscle mini-tenotomy (snip) surgery | Procedure or surgery | Convergence insufficiency, Divergence insufficiency, Small-angle hypertropia |
| Botox InjectionAlso: Botulinum toxin injectionBotulinum toxin injection | Procedure or surgery | Convergence insufficiency, Divergence insufficiency, Small-angle hypertropia |
Primary outcome
Number of Participants With Symptom Success at 10 Weeks
Time frame: 10 weeks after enrollment
In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.
Number of Participants With Symptom Success at 12 Months
Time frame: 12 months after enrollment
In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of <21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.
5 secondary outcomes
Mean of Near Point of Convergence in Convergence Insufficiency Group
Time frame: 12 months after enrollment
Mean Positive Fusional Vergence in Convergence Insufficiency Group
Time frame: 12 months after enrollment
Adult Strabismus 20 Questionnaire Score (DI)
Time frame: 12 months after enrollment
Mean Convergence Insufficiency Symptom Survey Score
Time frame: 12 months after enrollment
Adult Strabismus 20 Questionnaire Score (CI)
Time frame: 12 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34271207Crouch ER, Dean TW, Kraker RT, Miller AM, Kraus CL, Gunton KB, Repka MX, Marsh JD, Del Monte MA, Luke PA, Peragallo JH, Lee KA, Wheeler MB, Daley TJ, Wallace DK, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group. A prospective study of treatments for adult-onset divergence insufficiency-type esotropia. J AAPOS. 2021 Aug;25(4):203.e1-203.e11. doi: 10.1016/j.jaapos.2021.02.014. Epub 2021 Jul 13.
- Results publication: PubMed 35914096Lorenzana IJ, Leske DA, Hatt SR, Dean TW, Jenewein EC, Dagi LR, Beal CJ, Pang Y, Retnasothie DV, Esposito CA, Erzurum SA, Aldrich AE, Crouch ER, Li Z, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group. Relationships among Clinical Factors and Patient-reported Outcome Measures in Adults with Convergence Insufficiency. Optom Vis Sci. 2022 Sep 1;99(9):692-701. doi: 10.1097/OPX.0000000000001929. Epub 2022 Aug 2.
- PEDIG Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
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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.
Earl R Crouch, III, MD study chair
Virginia Pediatric Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Convergence Insufficiency and Divergence Insufficiency, run by Jaeb Center for Health Research at 1 site in United States.
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 0 inclusion and 33 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: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Symptom Success at 10 Weeks (time frame: 10 weeks after enrollment). 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?
On the ClinicalTrials.gov record for NCT02510040, which also lists 2 linked publications.
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 6 Jul 2023.