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Binocular Vision Anomalies After Cataract and Refractive Surgery

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ClinicalTrials.gov Identifier: NCT03592615
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Qing-Qing Tan, Salus University

Brief 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.


Condition or disease Intervention/treatment Phase
Binocular Vision Disorder Refractive Errors Cataract Procedure: cataract surgery Procedure: Corneal refractive surgery Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cataract group: participants undergo cataract surgery for vision correction Refractive error group: participants undergo corneal refractive surgery for vision correction
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevalence of Binocular Vision Anomalies Before and After Cataract and Refractive Surgery
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cataract group
All participants in this arm undergo cataract surgery for the purpose of vision correction.
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.
Other Names:
  • phacoemulsification
  • cataract extraction

Experimental: Refractive error group
All participants in this arm undergo corneal refractive surgery for the purpose of vision correction.
Procedure: 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.
Other Names:
  • LASIK
  • LASEK
  • PRK
  • SMILE




Primary Outcome Measures :
  1. Changes from pre-surgical phoria at 12 weeks post surgery [ Time Frame: Pre-surgery and 12 weeks post surgery ]
    Phoria will be measured using cover test (in prism diopters).

  2. Changes from pre-surgical fusional vergence at 12 weeks post surgery [ Time Frame: Pre-surgery and 12 weeks post surgery ]
    Fusional vergence will be measured using step vergence testing (in prism diopters).

  3. Changes from pre-surgical convergence amplitude at 12 weeks post surgery [ Time Frame: Pre-surgery and 12 weeks post surgery ]
    Convergence amplitude will be measured using near point of convergence test (in centimeters).

  4. Changes from pre-surgical vergence facility at 12 weeks post surgery [ Time Frame: Pre-surgery and 12 weeks post surgery ]
    Vergence facility will be measured using vergence facility testing (in cycle per minute).

  5. Changes from pre-surgical accommodative amplitude at 12 weeks post surgery (refractive error group only) [ Time Frame: Pre-surgery and 12 weeks post surgery ]
    Accommodative amplitude will be measured using monocular amplitude of accommodation testing (in diopters).

  6. Changes from pre-surgical accommodative facility at 12 weeks post surgery (refractive error group only) [ Time Frame: Pre-surgery and 12 weeks post surgery ]
    Accommodative facility will be measured using monocular accommodative facility testing (in cycle per minute).


Secondary Outcome Measures :
  1. changes from pre-surgical stereopsis at 12 weeks post surgery [ Time Frame: pre-surgery and 12 weeks post surgery ]
    Randot stereo test (recorded in second of arc)

  2. changes from pre-surgical aniseikonia at 12 weeks post surgery [ Time Frame: pre-surgery and 12 weeks post surgery ]
    Aniseikonia Inspector Software Program (recorded in percentage)

  3. changes from pre-surgical CISS score at 12 weeks post surgery [ Time Frame: pre-surgery and 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cataract patients who are willing to undergo cataract extraction and intraocular lens implantation
  • Refractive error patients who are willing to undergo laser corneal refractive surgery
  • 18 years and older in cataract group
  • 18-35 years old in refractive error group
  • Any gender
  • Any race or ethnicity
  • Informed consent and willingness to participate in the study

Exclusion Criteria:

  • Other ocular pathology that affect vision and binocular alignment in addition to cataract or refractive error
  • Surgical complications that may affect binocular vision testing, such as a subluxation of the IOLs or macular edema

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592615


Contacts
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Contact: Qing-Qing Tan, MSc 2674376245 tqq0720@gmail.com
Contact: Mitchell Scheiman, PhD 2157801427 mscheiman@salus.edu

Locations
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United States, Pennsylvania
Salus University Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Qing-Qing Tan, MSc    267-437-6245    tqq0720@gmail.com   
Contact: Mitchell Scheiman, PhD    2157801427    mscheiman@salus.edu   
Sponsors and Collaborators
Salus University
Investigators
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Principal Investigator: Qing-Qing Tan, MSc Salus University

Publications:

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Responsible Party: Qing-Qing Tan, PhD student, Salus University
ClinicalTrials.gov Identifier: NCT03592615     History of Changes
Other Study ID Numbers: qqt0001
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qing-Qing Tan, Salus University:
prevalence
binocular vision disorders
accommodative disorders
cataract surgery
corneal refractive surgery

Additional relevant MeSH terms:
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Cataract
Refractive Errors
Capsule Opacification
Vision Disorders
Lens Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms