Visual Function in Pediatric Patients With Posterior Lens Opacities

Visual Function in Pediatric Patients With Posterior Polar Cataracts and Posterior Lenticonus

Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated with the visual acuity after surgery. Patients enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

Study Overview

• Status: Completed
• Conditions: Congenital Cataract Polar Posterior
• Intervention / Treatment: Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation

Detailed Description

Congenital cataract patients have a wide range of presentations of lens opacities with different impact on visual function. Polar cataracts are opacities of the subcapsular cortex in the polar regions of the lens. To our knowledge, anterior polar cataracts are usually visually insignificant, however, even a small posterior lens opacity can impair vision because of their close proximity to the macula. Visual impairment could be caused by an opacity that blocks the visual axis, refractive error, posterior lesion-induced optical distortion, or amblyopia. Therefore, surgery is often recommended when visual function is significantly affected. The primary indication for surgical intervention in cataract is poor visual acuity. However, the previous studies have shown that preoperative visual acuity is a poor predictor of improvement in the subjectively experienced quality of vision after cataract surgery. Considering the increased risk for capsule rupture during surgery and the sacrifice of accommodation after cataract surgery in eyes with posterior lens opacities, the decision of surgical intervention must be carefully weighed.

In this trial, the investigators aimed to evaluate the changes of visual function, including visual acuity, modulation transfer function, ocular aberrations in the participants with posterior lens opacities. Moreover, various factors which might be associated with postoperative visual acuity were explored. The participants enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital posterior polar cataracts or posterior lenticonus who need cataract surgery at the Zhongshan Ophthalmic Center, Sun Yat-sen University in China were included. The patients who had relevant ocular disease other than congenital cataract or could not cooperate to the examinations were excluded. The indication for surgery in all patients was significantly deteriorated visual function and amblyopia treatment failure (decline in CDVA to 20/80 or worse). The study adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from each subject.

Description

Inclusion Criteria:

• Children with posterior polar cataracts or posterior lenticonus who need cataract surgery
• Aged 3-14 years
• Have signed a consent form
• Can be followed

Exclusion Criteria:

• Have relevant ocular disease other than congenital cataract
• Could not cooperate to the examinations

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
posterior polar cataracts; Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients. Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.	Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation; Phacomulsification lens removal cataract surgery with IOL implantation in both two groups
posterior lenticonus; Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients. Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.	Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation; Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity (BCVA)	Visual acuity (BCVA) measured by ETDRS chart after surgery	6 month after surgery
Stereoacuity	Stereoacuity measured at 40 cm using the Randot stereotests	6 month after surgery
modulation transfer function (MTF)	MTF measured with the Optical Quality Analysis System	6 month after surgery
monochromatic aberrations	monochromatic aberrations measured by the iTrace Dynamic Laser Refraction	6 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of the cataracts	divided into central, paracentral, and peripheral	before surgery
size of lens lesion	measured by image J	before surgery
Visual acuity (BCVA)	Visual acuity (BCVA) measured by ETDRS chart before surgery	before surgery
Stereoacuity	Stereoacuity measured at 40 cm using the Randot stereotests	before surgery
modulation transfer function (MTF)	MTF measured with the Optical Quality Analysis System	before surgery
monochromatic aberrations	monochromatic aberrations measured by the iTrace Dynamic Laser Refraction system	before surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Weirong Chen, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2020
• Primary Completion (ACTUAL): August 29, 2021
• Study Completion (ACTUAL): August 29, 2021

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (ACTUAL): January 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: visual function; posterior polar cataracts; posterior lenticonus
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2020-China20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No