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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03592615
Other study ID # qqt0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2019
Est. completion date November 26, 2019

Study information

Verified date March 2020
Source Salus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are indications in the literature that binocular vision disorders may occur after cataract and corneal refractive surgery. It is not clear whether these problems are new or represent decompensation of previously existing conditions. However, the following significant study limitations exist in the current literature: 1) lack of attention to non-strabismic binocular vision disorders, 2) incomplete binocular vision assessment, 3) a validated symptom survey was not used, 4) diplopia was typically the only symptom studied, 5) retrospective study design, and 6) in the few prospective studies the sample sizes were small.

Given the limitations in the current literature there is a need for further study of the prevalence and significance of binocular vision problems after cataract surgery and binocular vision and accommodative problems after corneal refractive surgery.

This study aims to determine whether there is an increase in the prevalence of binocular vision problems after cataract surgery and accommodative and binocular vision disorders after refractive surgery.


Description:

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Study Design


Intervention

Procedure:
cataract surgery
Cataract surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than cataract, e.g., treatment for lens dislocation. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating astigmatism.
Corneal refractive surgery
Corneal refractive surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than refractive error, e.g., treatment for corneal scar. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating severe astigmatism.

Locations

Country Name City State
United States Salus University Elkins Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Salus University

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Outcome

Type Measure Description Time frame Safety issue
Primary Changes from pre-surgical phoria at 12 weeks post surgery Phoria will be measured using cover test (in prism diopters). Pre-surgery and 12 weeks post surgery
Primary Changes from pre-surgical fusional vergence at 12 weeks post surgery Fusional vergence will be measured using step vergence testing (in prism diopters). Pre-surgery and 12 weeks post surgery
Primary Changes from pre-surgical convergence amplitude at 12 weeks post surgery Convergence amplitude will be measured using near point of convergence test (in centimeters). Pre-surgery and 12 weeks post surgery
Primary Changes from pre-surgical vergence facility at 12 weeks post surgery Vergence facility will be measured using vergence facility testing (in cycle per minute). Pre-surgery and 12 weeks post surgery
Primary Changes from pre-surgical accommodative amplitude at 12 weeks post surgery (refractive error group only) Accommodative amplitude will be measured using monocular amplitude of accommodation testing (in diopters). Pre-surgery and 12 weeks post surgery
Primary Changes from pre-surgical accommodative facility at 12 weeks post surgery (refractive error group only) Accommodative facility will be measured using monocular accommodative facility testing (in cycle per minute). Pre-surgery and 12 weeks post surgery
Secondary changes from pre-surgical stereopsis at 12 weeks post surgery Randot stereo test (recorded in second of arc) pre-surgery and 12 weeks post surgery
Secondary changes from pre-surgical aniseikonia at 12 weeks post surgery Aniseikonia Inspector Software Program (recorded in percentage) pre-surgery and 12 weeks post surgery
Secondary changes from pre-surgical CISS score at 12 weeks post surgery Convergence insufficiency symptom survey (recorded in a summation of the CISS score). The CISS is a 15-items survey questioning the participants whether they have the symptoms related to binocular vision disorders. Each item has a scale ranging from 0 to 4, of which 0=never, 1=not very often, 2=sometimes, 3=fairly often, 4=always. A higher score indicates a worse outcome. The total score will be summed from the 15 items. pre-surgery and 12 weeks post surgery
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