NCT03592615

Binocular Vision Anomalies After Cataract and Refractive Surgery

Completed NA Last updated 18 March 2020

What this trial tests

NA trial testing cataract surgery in Binocular Vision Disorder in 51 participants. Completed in 26 November 2019.

Timeline

8 January 2019

Primary endpoint
26 November 2019

26 November 2019

Quick facts

Lead sponsor	Salus University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	51
Start date	8 January 2019
Primary completion	26 November 2019
Estimated completion	26 November 2019
Sites	1 location across United States

Drugs / interventions tested

• cataract surgery — full drug profile →
• Corneal refractive surgery

Conditions studied

• Binocular Vision Disorder — all drugs for Binocular Vision Disorder →
• Refractive Errors — all drugs for Refractive Errors →
• Cataract — all drugs for Cataract →

Sponsor

Salus University

Who can join

18 and older, any sex, with Binocular Vision Disorder or Refractive Errors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preoperative binocular vision characteristics in the age-related cataract population.
   Tan QQ, Lewis JS, Lan CJ, Liao X, et al · · 2022 · cited 6× · PMID 35477368 · DOI 10.1186/s12886-022-02418-7
2. Cataract surgery is not associated with post-operative binocular vision anomalies in age-related cataract patients.
   Tan QQ, Lewis JS, Lan CJ, Liao X, et al · · 2022 · cited 3× · PMID 35690924 · DOI 10.1111/opo.13012
3. A brief effective screening protocol for identifying cataract patients with binocular vision anomalies.
   Tan QQ, Tan JH, Luo CK, Lai CY, et al · · 2024 · PMID 39695508 · DOI 10.1186/s12886-024-03807-w
4. Preoperative Binocular Vision Characteristics in the Age-related Cataract Population
   Tan Q, Lewis J, Lan C, Liao X, et al · · 2021 · DOI 10.21203/rs.3.rs-621693/v1