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Binocular Vision Anomalies After Cataract and Refractive Surgery

Primary Purpose

Binocular Vision Disorder, Refractive Errors, Cataract

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cataract surgery

Corneal refractive surgery

About this trial

This is an interventional prevention trial for Binocular Vision Disorder focused on measuring prevalence, binocular vision disorders, accommodative disorders, cataract surgery, corneal refractive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Salus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cataract group

Refractive error group

Arm Description

All participants in this arm undergo cataract surgery for the purpose of vision correction.

All participants in this arm undergo corneal refractive surgery for the purpose of vision correction.

Outcomes

Primary Outcome Measures

Changes from pre-surgical phoria at 12 weeks post surgery

Phoria will be measured using cover test (in prism diopters).

Changes from pre-surgical fusional vergence at 12 weeks post surgery

Fusional vergence will be measured using step vergence testing (in prism diopters).

Changes from pre-surgical convergence amplitude at 12 weeks post surgery

Convergence amplitude will be measured using near point of convergence test (in centimeters).

Changes from pre-surgical vergence facility at 12 weeks post surgery

Vergence facility will be measured using vergence facility testing (in cycle per minute).

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).

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).

Secondary Outcome Measures

changes from pre-surgical stereopsis at 12 weeks post surgery

Randot stereo test (recorded in second of arc)

changes from pre-surgical aniseikonia at 12 weeks post surgery

Aniseikonia Inspector Software Program (recorded in percentage)

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.

Full Information

NCT ID

NCT03592615

First Posted

June 8, 2018

Last Updated

March 16, 2020

Sponsor

Salus University

1. Study Identification

Unique Protocol Identification Number

NCT03592615

Brief Title

Binocular Vision Anomalies After Cataract and Refractive Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 8, 2019 (Actual)

Primary Completion Date

November 26, 2019 (Actual)

Study Completion Date

November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Salus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Binocular Vision Disorder, Refractive Errors, Cataract

Keywords

prevalence, binocular vision disorders, accommodative disorders, cataract surgery, corneal refractive surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cataract group

Arm Type

Experimental

Arm Description

All participants in this arm undergo cataract surgery for the purpose of vision correction.

Arm Title

Refractive error group

Arm Type

Experimental

Arm Description

All participants in this arm undergo corneal refractive surgery for the purpose of vision correction.

Intervention Type

Procedure

Intervention Name(s)

cataract surgery

Other Intervention Name(s)

phacoemulsification, cataract extraction

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Corneal refractive surgery

Other Intervention Name(s)

LASIK, LASEK, PRK, SMILE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes from pre-surgical phoria at 12 weeks post surgery

Description

Phoria will be measured using cover test (in prism diopters).

Time Frame