Binocular Vision Anomalies After Cataract and Refractive Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592615
• Other study ID #: qqt0001
• Status: Completed
• Phase: N/A
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Binocular Vision Disorder
• Capsule Opacification
• Cataract
• Refractive Errors
• Vision Disorders

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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Chung SA, Kim CY, Chang JH, Hong S, Kang SY, Seong GJ, Lee JB. Change in ocular alignment after topical anesthetic cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2009 Sep;247(9):1269-72. doi: 10.1007/s00417-009-1084-8. Epub 2009 Apr 30. — View Citation

Chung SA, Kim WK, Moon JW, Yang H, Kim JK, Lee SB, Lee JB. Impact of laser refractive surgery on ocular alignment in myopic patients. Eye (Lond). 2014 Nov;28(11):1321-7. doi: 10.1038/eye.2014.209. Epub 2014 Sep 5. — View Citation

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Finlay AL. Binocular vision and refractive surgery. Cont Lens Anterior Eye. 2007 May;30(2):76-83. Review. — View Citation

García-Muñoz Á, Carbonell-Bonete S, Cantó-Cerdán M, Cacho-Martínez P. Accommodative and binocular dysfunctions: prevalence in a randomised sample of university students. Clin Exp Optom. 2016 Jul;99(4):313-21. doi: 10.1111/cxo.12376. Epub 2016 Mar 29. — View Citation

Gawecki M, Grzybowski A. Diplopia as the Complication of Cataract Surgery. J Ophthalmol. 2016;2016:2728712. doi: 10.1155/2016/2728712. Epub 2016 Feb 21. Review. — View Citation

Giannaccare G, Primavera L, Fresina M. Photorefractive keratectomy influences the angle of ocular deviation in strabismus patients with hyperopia. Int Ophthalmol. 2019 Apr;39(4):737-744. doi: 10.1007/s10792-018-0867-5. Epub 2018 Mar 3. — View Citation

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Han J, Hong S, Lee S, Kim JK, Lee HK, Han SH. Changes in fusional vergence amplitudes after laser refractive surgery for moderate myopia. J Cataract Refract Surg. 2014 Oct;40(10):1670-5. doi: 10.1016/j.jcrs.2014.01.043. Epub 2014 Aug 20. — View Citation

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Kalantzis G, Papaconstantinou D, Karagiannis D, Koutsandrea C, Stavropoulou D, Georgalas I. Post-cataract surgery diplopia: aetiology, management and prevention. Clin Exp Optom. 2014 Sep;97(5):407-10. doi: 10.1111/cxo.12197. Review. — View Citation

Karagiannis D, Chatzistefanou K, Damanakis A. Prevalence of diplopia related to cataract surgery among cases of diplopia. Eur J Ophthalmol. 2007 Nov-Dec;17(6):914-8. — View Citation

Karimian F, Baradaran-Rafii A, Bagheri A, Eslani M, Bayat H, Aramesh S, Yaseri M, Amin-Shokravi A. Accommodative changes after photorefractive keratectomy in myopic eyes. Optom Vis Sci. 2010 Nov;87(11):833-8. doi: 10.1097/OPX.0b013e3181f6fccc. — View Citation

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Loba P, Rajska K, Simiera J, Wilczynski M, Omulecki W, Broniarczyk-Loba A. The influence of a prolonged interoperative period on binocular vision after bilateral cataract extractions. Eur J Ophthalmol. 2015 Jul-Aug;25(4):315-9. doi: 10.5301/ejo.5000569. Epub 2015 Jan 27. — View Citation

Minnal VR, Rosenberg JB. Refractive surgery: a treatment for and a cause of strabismus. Curr Opin Ophthalmol. 2011 Jul;22(4):222-5. doi: 10.1097/ICU.0b013e3283477c60. Review. — View Citation

Nayak H, Kersey JP, Oystreck DT, Cline RA, Lyons CJ. Diplopia following cataract surgery: a review of 150 patients. Eye (Lond). 2008 Aug;22(8):1057-64. Epub 2007 Apr 27. — View Citation

Prakash G, Choudhary V, Sharma N, Titiyal JS. Change in the accommodative convergence per unit of accommodation ratio after bilateral laser in situ keratomileusis for myopia in orthotropic patients: prospective evaluation. J Cataract Refract Surg. 2007 Dec;33(12):2054-6. — View Citation

Rutstein RP, Fullard RJ, Wilson JA, Gordon A. Aniseikonia induced by cataract surgery and its effect on binocular vision. Optom Vis Sci. 2015 Feb;92(2):201-7. doi: 10.1097/OPX.0000000000000491. — View Citation

Snir M, Kremer I, Weinberger D, Sherf I, Axer-Siegel R. Decompensation of exodeviation after corneal refractive surgery for moderate to high myopia. Ophthalmic Surg Lasers Imaging. 2003 Sep-Oct;34(5):363-70. — View Citation

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* Note: There are 26 references in all — Click here to view all references

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