Binocular Vision Anomalies After Cataract and Refractive Surgery
NCT ID: NCT03592615
Last Updated: 2020-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
51 participants
INTERVENTIONAL
2019-01-08
2019-11-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Correction of Refractive Error Surprises After Cataract Surgery in Adults
NCT06379477
Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
NCT06924944
Subjective and Objective Refraction in Pseudophakic Patients
NCT04319497
Binocular Vision in Monocular Pseudophakia
NCT01872000
Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
NCT01763411
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cataract group
All participants in this arm undergo cataract surgery for the purpose of vision correction.
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.
Refractive error group
All participants in this arm undergo corneal refractive surgery for the purpose of vision correction.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Surgical complications that may affect binocular vision testing, such as a subluxation of the IOLs or macular edema
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Salus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qing-Qing Tan
PhD student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qing-Qing Tan, MSc
Role: PRINCIPAL_INVESTIGATOR
Salus University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Salus University
Elkins Park, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Finlay AL. Binocular vision and refractive surgery. Cont Lens Anterior Eye. 2007 May;30(2):76-83. doi: 10.1016/j.clae.2007.02.009.
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.
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.
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.
Golnik KC, West CE, Kaye E, Corcoran KT, Cionni RJ. Incidence of ocular misalignment and diplopia after uneventful cataract surgery. J Cataract Refract Surg. 2000 Aug;26(8):1205-9. doi: 10.1016/s0886-3350(00)00330-8.
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. doi: 10.1038/sj.eye.6702847. Epub 2007 Apr 27.
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. doi: 10.1177/112067210701700608.
Hutchinson AK. Refractive surgery for accommodative esotropia: past, present, and future. Eur J Ophthalmol. 2012 Nov-Dec;22(6):871-7. doi: 10.5301/ejo.5000210. Epub 2012 Oct 10.
Kirwan C, O'Keefe M, O'Mullane GM, Sheehan C. Refractive surgery in patients with accommodative and non-accommodative strabismus: 1-year prospective follow-up. Br J Ophthalmol. 2010 Jul;94(7):898-902. doi: 10.1136/bjo.2009.162420. Epub 2009 Nov 30.
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.
Kushner BJ, Kowal L. Diplopia after refractive surgery: occurrence and prevention. Arch Ophthalmol. 2003 Mar;121(3):315-21. doi: 10.1001/archopht.121.3.315.
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.
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. doi: 10.1016/j.jcrs.2007.07.030.
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.
Li M, Cheng H, Yuan Y, Wang J, Chen Q, Me R, Ke B. Change in choroidal thickness and the relationship with accommodation following myopic excimer laser surgery. Eye (Lond). 2016 Jul;30(7):972-8. doi: 10.1038/eye.2016.75. Epub 2016 Apr 15.
Zheng K, Han T, Zhou X. Accommodative changes after SMILE for moderate to high myopia correction. BMC Ophthalmol. 2016 Oct 4;16(1):173. doi: 10.1186/s12886-016-0352-8.
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.
Wylie J, Henderson M, Doyle M, Hickey-Dwyer M. Persistent binocular diplopia following cataract surgery: aetiology and management. Eye (Lond). 1994;8 ( Pt 5):543-6. doi: 10.1038/eye.1994.134.
Godts D, Trau R, Tassignon MJ. Effect of refractive surgery on binocular vision and ocular alignment in patients with manifest or intermittent strabismus. Br J Ophthalmol. 2006 Nov;90(11):1410-3. doi: 10.1136/bjo.2006.090902. Epub 2006 Aug 2.
Brugnoli de Pagano OM, Pagano GL. Laser in situ keratomileusis for the treatment of refractive accommodative esotropia. Ophthalmology. 2012 Jan;119(1):159-63. doi: 10.1016/j.ophtha.2011.07.003. Epub 2011 Sep 29.
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.
Garcia-Munoz A, Carbonell-Bonete S, Canto-Cerdan M, Cacho-Martinez 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.
Dupont WD. Power calculations for matched case-control studies. Biometrics. 1988 Dec;44(4):1157-68.
Tan QQ, Tan JH, Luo CK, Lai CY, Zhao W, Lan CJ, Lewis J, Aljohani S, Liao X, Scheiman M. A brief effective screening protocol for identifying cataract patients with binocular vision anomalies. BMC Ophthalmol. 2024 Dec 18;24(1):536. doi: 10.1186/s12886-024-03807-w.
Tan QQ, Lewis JS, Lan CJ, Liao X, Tang XL, Wang J, Aljohani S, Scheiman MM. Cataract surgery is not associated with post-operative binocular vision anomalies in age-related cataract patients. Ophthalmic Physiol Opt. 2022 Sep;42(5):998-1008. doi: 10.1111/opo.13012. Epub 2022 Jun 12.
Tan QQ, Lewis JS, Lan CJ, Liao X, Tang XL, Wang J, Scheiman MM. Preoperative binocular vision characteristics in the age-related cataract population. BMC Ophthalmol. 2022 Apr 27;22(1):196. doi: 10.1186/s12886-022-02418-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
qqt0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.