Trial Outcomes & Findings for A Prospective Observational Study of Adult Strabismus (NCT NCT02510040)

NCT ID: NCT02510040

Last Updated: 2023-07-06

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 217 participants
• Primary outcome timeframe: 10 weeks after enrollment
• Results posted on: 2023-07-06

Participant Flow

Participant milestones

Measure	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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Overall Study STARTED	81	114	22
Overall Study COMPLETED	63	111	21
Overall Study NOT COMPLETED	18	3	1

Reasons for withdrawal

Measure	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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Overall Study Deemed no longer eligible	18	3	1

Baseline Characteristics

A Prospective Observational Study of Adult Strabismus

Baseline characteristics by cohort

Measure	Convergence Insufficiency n=63 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Divergence Insufficiency n=111 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Small-angle Hypertropia n=21 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Total n=195 Participants Total of all reporting groups
Age, Continuous	38.2 years n=5 Participants	71.2 years n=7 Participants	71.5 years n=5 Participants	65.3 years n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	74 Participants n=7 Participants	10 Participants n=5 Participants	132 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	37 Participants n=7 Participants	11 Participants n=5 Participants	63 Participants n=4 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants	107 Participants n=7 Participants	19 Participants n=5 Participants	158 Participants n=4 Participants
Race/Ethnicity, Customized Non-white	31 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	37 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Convergence Insufficiency n=54 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Divergence Insufficiency n=104 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Small-angle Hypertropia n=21 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Number of Participants With Symptom Success at 10 Weeks	25 Participants	91 Participants	12 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Convergence Insufficiency n=54 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Divergence Insufficiency n=98 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection	Small-angle Hypertropia n=18 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Number of Participants With Symptom Success at 12 Months	25 Participants	73 Participants	6 Participants

SECONDARY outcome

Timeframe: 12 months after enrollment

Near point of convergence (convergence insufficiency group only).

Outcome measures

Measure	Convergence Insufficiency n=57 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Mean of Near Point of Convergence in Convergence Insufficiency Group	14.1 centimeters Standard Deviation 6.2	—	—

SECONDARY outcome

Timeframe: 12 months after enrollment

Positive fusional vergence (convergence insufficiency group only).

Outcome measures

Measure	Convergence Insufficiency n=57 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Mean Positive Fusional Vergence in Convergence Insufficiency Group	11.6 prism diopters Standard Deviation 7.1	—	—

SECONDARY outcome

Timeframe: 12 months after enrollment

Population: This information was only collected and analyzed for the DI and CI arms. The HT arm cannot be reported since it was not collected. The CI arm data is currently being analyzed, and will be added to the record when analysis is complete, results are expected May 2021.

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.

1. Self-perception score

2. Interaction score

3. Reading function score

4. 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)

Outcome measures

Measure	Convergence Insufficiency n=111 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Adult Strabismus 20 Questionnaire Score (DI) General Function Score	62 score on a scale Standard Deviation 22	—	—
Adult Strabismus 20 Questionnaire Score (DI) Reading Function Score	71 score on a scale Standard Deviation 23	—	—
Adult Strabismus 20 Questionnaire Score (DI) Self Perception Score	87 score on a scale Standard Deviation 19	—	—
Adult Strabismus 20 Questionnaire Score (DI) Interaction Score	94 score on a scale Standard Deviation 11	—	—

SECONDARY outcome

Timeframe: 12 months after enrollment

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).

Outcome measures

Measure	Convergence Insufficiency n=57 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Mean Convergence Insufficiency Symptom Survey Score	37.5 points Standard Deviation 9.1	—	—

SECONDARY outcome

Timeframe: 12 months after enrollment

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)

Outcome measures

Measure	Convergence Insufficiency n=57 Participants 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin 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. Prism: Ground-in or Fresnel prism Orthoptic Exercises: Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy 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 Botox Injection: Botulinum toxin injection
Adult Strabismus 20 Questionnaire Score (CI) Interaction	92.2 points Standard Deviation 14.7	—	—
Adult Strabismus 20 Questionnaire Score (CI) General Function	55.7 points Standard Deviation 24.6	—	—
Adult Strabismus 20 Questionnaire Score (CI) Reading Function	43.9 points Standard Deviation 22.2	—	—
Adult Strabismus 20 Questionnaire Score (CI) Self Perception	83.8 points Standard Deviation 22.6	—	—

Adverse Events

Convergence Insufficiency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Divergence Insufficiency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Small-angle Hypertropia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Kraker, PEDIG Coordinating Center Director

Jaeb Center for Health Research

Phone: 813-975-8690

Email: rkraker@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place