A Prospective Observational Study of Adult Strabismus

NCT02510040 | Completed Results DMC

• 2 other identifiers: SAS12U10EY011751
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Convergence Insufficiency; Divergence Insufficiency; Hypertropia

Keywords

Convergence Insufficiency; Divergence Insufficiency; Small-angle Hypertropia; Strabismus

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months after enrollment

Secondary Outcomes (5)

• Mean of Near Point of Convergence in Convergence Insufficiency Group

  12 months after enrollment

• Mean Positive Fusional Vergence in Convergence Insufficiency Group

  12 months after enrollment

• Adult Strabismus 20 Questionnaire Score (DI)

  12 months after enrollment

• Mean Convergence Insufficiency Symptom Survey Score

  12 months after enrollment

• Adult Strabismus 20 Questionnaire Score (CI)

  12 months after enrollment

Study Arms (3)

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.

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.

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.

Device: Prism; Other: Orthoptic Exercises; Procedure: Eye Muscle Surgery; Procedure: Botox Injection

Interventions

Prism DEVICE

Ground-in or Fresnel prism

Convergence insufficiency; Divergence insufficiency; Small-angle hypertropia

Orthoptic Exercises OTHER

Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy

Convergence insufficiency; Divergence insufficiency; Small-angle hypertropia

Eye Muscle Surgery PROCEDURE

* 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

Convergence insufficiency; Divergence insufficiency; Small-angle hypertropia

Botox Injection PROCEDURE

Botulinum toxin injection

Also known as: Botulinum toxin injection

Convergence insufficiency; Divergence insufficiency; Small-angle hypertropia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• Adults ≥18 years of age (adult onset of CI not required)
• No strabismus surgery within the past 10 years
• CI Symptom Survey score ≥21 points
• Near exodeviation of ≥4∆ and at least 4∆ larger than at distance by PACT
• Distance exodeviation ≤15∆ by PACT
• Vertical deviation ≤2∆ at distance and near by PACT
• No constant exotropia at distance or near
• Reduced positive fusional vergence (PFV) at near (\<20∆ or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria)
• Near point of convergence (NPC) of ≥6 cm break
• Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
• No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
• No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
• No monocular diplopia
• No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
• No inferior or superior oblique overaction defined as 2+ or greater

You may not qualify if:

• The following criteria exclude a subject from enrollment into the study:
• Strabismus surgery within the past 10 years
• CI Symptom Survey score ≥21 points
• Near exodeviation of ≤4∆ and at least 4∆ larger than at distance by PACT
• Distance exodeviation ≥15∆ by PACT
• Vertical deviation ≥2∆ at distance and near by PACT
• Constant exotropia at distance or near
• Near point of convergence (NPC) of ≤6 cm break
• Visual acuity worse than 20/50 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. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
• Inferior or superior oblique overaction defined as 2+ or greater
• Inability to fuse with prism in space (see section 2.4.1)

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

Earl R. Crouch, III

Norfolk, Virginia, 23502-3942, United States

Location

Related Publications (2)

• 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.

  PMID: 34271207 RESULT

• Lorenzana 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.

  PMID: 35914096 RESULT

Related Links

• PEDIG Public Website

MeSH Terms

Conditions

Ocular Motility Disorders; Strabismus

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Raymond Kraker, PEDIG Coordinating Center Director
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

813-975-8690

Study Officials

• Earl R Crouch, III, MD

  Virginia Pediatric Eye Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 28, 2015
• Study Start: August 17, 2015
• Primary Completion: December 31, 2017
• Study Completion: January 31, 2019
• Last Updated: July 6, 2023
• Results First Posted: April 8, 2021

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the protocol and publication of the primary manuscript, the data will be made available for the duration of the grant and any future grants.
• Access Criteria: public

Locations

US (1)