Binocular Vision Anomalies After Cataract and Refractive Surgery

March 16, 2020 updated by: Qing-Qing Tan, Salus University

Prevalence of Binocular Vision Anomalies Before and After Cataract and Refractive Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Research plan Specific aim 1A: To investigate the prevalence of non-strabismic and strabismic binocular vision anomalies after cataract surgery. Specific aim 1B: To investigate the prevalence accommodative and binocular vision disorders after refractive surgery. Specific aim 2: To determine if increase in the prevalence of binocular anomalies is different for cataract surgery compared to refractive surgery. Specific aim 3: To develop an efficient examination protocol that would enable eye care professionals to determine if a patient is at risk for binocular vision anomalies after cataract surgery and accommodative and binocular vision disorders after refractive surgery.

    The proposed study will address the weaknesses in the current literature. The study will be prospective and will use explicit and well-defined eligibility and exclusion criteria. A comprehensive battery of accommodative (pre-presbyopes only) and binocular vision tests will be administered on all the patients before the surgery of the first eye and 12 weeks after the surgery of the second eye.

    A pre-defined classification protocol will be used to determine if a binocular vision disorder is present before surgery, after surgery, or whether there has been a change in the condition after surgery.

    A total prevalence of postoperative strabismic and non-strabismic binocular vision anomalies will be determined for the cataract population and the refractive error group.

  2. Statistical analysis plan 2.1 Specific aim 1A Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision anomalies after cataract surgery

A sample size calculation based on a McNemar's test to compare the prevalence of binocular vision anomalies before and after cataract surgery was performed using the Power and Sample Size Program (PS version 3.1.2). Base on a previous literature, the overall prevalence of accommodative and binocular vision anomalies in adult population (18-35 years) is 13.15%. However, no existing literature reported the prevalence of binocular vision anomalies after cataract surgery.

We propose that 15% increase in prevalence is clinically meaningful. The correlation between paired observations is 0.2, as recommended by Dupont. Although this is a large effect, the effect of cataract surgery on prevalence of binocular vision anomalies may be this large (presumed by an experienced binocular vision specialist). If the effect is smaller and the difference not statistically significant, the study will provide valuable data to plan another study. Therefore, a sample size calculation suggests that a total of 44 participants will yield a power of 80% with a significant level of 5%. To account for potential loss to follow-up, a sample size of 50 will be selected for the cataract group. All analyses will be performed using SPSS Statistics 24.0 with an alpha level of 0.05 to determine the statistical significance. A calculation for the prevalence of binocular vision anomalies before and after surgery will be performed. A two-tailed McNemar's Chi-Square Test will be used to test the statistical significance of the change in the proportion of binocular vision anomalies before and after surgery.

2.2 Specific aim 1B Hypothesis: There will be a statistically significant increase in the prevalence of binocular vision and accommodative anomalies after refractive surgery.

The sample size calculation process for specific aim 1B was the same as for specific aim 1A. Therefore, a sample size of 50 will also be selected for the refractive error group. A calculation for the prevalence of accommodative and binocular vision anomalies before and after surgery will be performed. A two-tailed McNemar's Chi-Square Test will be used to test the statistical significance of the changes in the proportions of binocular vision anomalies before and after surgery.

2.3 Specific aim 2 Hypothesis: The increase in prevalence of binocular vision anomalies will be greater after cataract surgery than refractive surgery.

A calculation for the prevalence of binocular vision anomalies will be performed respectively in the cataract group and the refractive error group. A two-tailed Contingency Chi-Square Test will be used to test the statistical significance of difference of changes in the proportion of binocular vision anomalies before and after surgery in both groups.

2.4 Specific aim 3 Hypothesis: A short screening protocol will be of equal effectiveness to a comprehensive assessment of binocular vision and accommodation to determine which patients may be at risk for post-surgical binocular vision and accommodative anomalies.

A two-tailed MacNemar's Chi-Square Test will be used to test the statistical significance of difference in the effectiveness of a short screening protocol and a comprehensive assessment for determining the risk for post-surgical binocular vision and accommodative anomalies. Sensitivity and specificity for the short screening protocol will be calculated.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Salus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • SMILE
  • LASIK
  • LASEK
  • PRK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Pre-surgery and 12 weeks post surgery
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).
Pre-surgery and 12 weeks post surgery
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).
Pre-surgery and 12 weeks post surgery
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).
Pre-surgery and 12 weeks post surgery
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).
Pre-surgery and 12 weeks post surgery
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).
Pre-surgery and 12 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
pre-surgery and 12 weeks post surgery
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)
pre-surgery and 12 weeks post surgery
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.
pre-surgery and 12 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salus University

Investigators

  • Principal Investigator: Qing-Qing Tan, MSc, Salus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2019

Primary Completion (Actual)

November 26, 2019

Study Completion (Actual)

November 26, 2019

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qqt0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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