Binocular Vision Anomalies After Cataract and Refractive Surgery

NCT03592615 | Completed

• 1 other identifier: qqt0001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Binocular Vision Disorder; Refractive Errors; Cataract

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• changes from pre-surgical stereopsis at 12 weeks post surgery

  pre-surgery and 12 weeks post surgery

• changes from pre-surgical aniseikonia at 12 weeks post surgery

  pre-surgery and 12 weeks post surgery

• changes from pre-surgical CISS score at 12 weeks post surgery

  pre-surgery and 12 weeks post surgery

Study Arms (2)

Cataract group

EXPERIMENTAL

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

Procedure: cataract surgery

Refractive error group

EXPERIMENTAL

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

Procedure: Corneal refractive surgery

Interventions

cataract surgery PROCEDURE

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.

Also known as: phacoemulsification, cataract extraction

Cataract group

Corneal refractive surgery PROCEDURE

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.

Also known as: LASIK, LASEK, PRK, SMILE

Refractive error group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years and older in cataract group
• years old in refractive error group
• Any gender
• Any race or ethnicity
• Informed consent and willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

Salus University

Elkins Park, Pennsylvania, 19027, United States

Location

Related Publications (29)

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• 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.

  PMID: 39695508 DERIVED

• 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.

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• 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.

  PMID: 35477368 DERIVED

MeSH Terms

Conditions

Refractive Errors; Cataract

Interventions

Cataract Extraction; Phacoemulsification; Keratomileusis, Laser In Situ; Keratectomy, Subepithelial, Laser-Assisted

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Keratectomy

Study Officials

• Qing-Qing Tan, MSc

  Salus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Cataract group: participants undergo cataract surgery for vision correction Refractive error group: participants undergo corneal refractive surgery for vision correction

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 19, 2018
• Study Start: January 8, 2019
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)