Multicenter Study on Quality of Life Improvement in Adults with Acquired Diplopia Treated with Prism Correction and Vergence-Based Vision Therapy

Multicenter Study on Quality of Life Improvement in Adults with Acquired Diplopia Treated with Prism Correction and Vergence-Based Vision Therapy - DIP-QoL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039531

Enrollment

100

Registered

2026-03-13

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H53.2

Interventions

Group 1: All participants initially receive prism correction (Phase I). Participants in whom prism correction fails proceed to Phase II, consisting of vergence-based visual/orthoptic therapy combined

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Adults aged 18 years or older. - Presence of acquired diplopia secondary to strabismus. - Diplopia present for at least three months. - Ability and willingness to participate in the study and to provide written informed consent.

Exclusion criteria

Exclusion criteria: - Severe amblyopia (best corrected visual acuity < 0.2). - Monocular diplopia. - Presence of nystagmus. - Diplopia secondary to decompensated childhood strabismus. - Supranuclear, internuclear, or nuclear ocular motility disorders. - Cognitive impairment or intellectual disability preventing completion of the AS-20 and Diplopia Questionnaire (DQ).

Design outcomes

Primary

Measure	Time frame
Treatment success defined as absence of diplopia in primary gaze and reading position, measured using the Diplopia Questionnaire (DQ). Outcomes will be assessed after one month of prism correction (Phase I) and after completion of vergence therapy when applicable (Phase II).	—

Secondary

Measure	Time frame
- Change in health-related quality of life measured using the Adult Strabismus Quality of Life Questionnaire (AS-20). Baseline, 1 month after prism correction, and at the end of Phase II treatment. - Changes in ocular deviation, fusional vergence ampitude and stereoacuity. Baseline and end of treatment. - Comparison of treatment success between prism placement in the dominant eye versus the non-dominant eye during Phase II. End of Phase II treatment. -Adherence to prism correction measured through a daily patient self-reported usage log indicating whether prism glasses were worn during most of the day. During Phase I and Phase II treatment periods. - Adherence to home-based vergence therapy measured through software usage data from the Visionary platform. During Phase II treatment.	—

Measure

Time frame

- Change in health-related quality of life measured using the Adult Strabismus Quality of Life Questionnaire (AS-20). Baseline, 1 month after prism correction, and at the end of Phase II treatment. - Changes in ocular deviation, fusional vergence ampitude and stereoacuity. Baseline and end of treatment. - Comparison of treatment success between prism placement in the dominant eye versus the non-dominant eye during Phase II. End of Phase II treatment. -Adherence to prism correction measured through a daily patient self-reported usage log indicating whether prism glasses were worn during most of the day. During Phase I and Phase II treatment periods. - Adherence to home-based vergence therapy measured through software usage data from the Visionary platform. During Phase II treatment.

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Countries

Colombia, Portugal, Spain

Contacts

Public ContactJuan Antonio Portela

Clinica Begira

juanportel@hotmail.com+34 691186577

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026