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Visual Function in Pediatric Patients With Posterior Lens Opacities

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05207007
Enrollment
63
Registered
2022-01-25
Start date
2020-01-04
Completion date
2021-08-29
Last updated
2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cataract Polar Posterior

Keywords

visual function, posterior polar cataracts, posterior lenticonus

Brief summary

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.

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.

Interventions

PROCEDUREPhacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation

Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 14 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity (BCVA)6 month after surgeryVisual acuity (BCVA) measured by ETDRS chart after surgery
Stereoacuity6 month after surgeryStereoacuity measured at 40 cm using the Randot stereotests
modulation transfer function (MTF)6 month after surgeryMTF measured with the Optical Quality Analysis System
monochromatic aberrations6 month after surgerymonochromatic aberrations measured by the iTrace Dynamic Laser Refraction

Secondary

MeasureTime frameDescription
modulation transfer function (MTF)before surgeryMTF measured with the Optical Quality Analysis System
Location of the cataractsbefore surgerydivided into central, paracentral, and peripheral
monochromatic aberrationsbefore surgerymonochromatic aberrations measured by the iTrace Dynamic Laser Refraction system
size of lens lesionbefore surgerymeasured by image J
Visual acuity (BCVA)before surgeryVisual acuity (BCVA) measured by ETDRS chart before surgery
Stereoacuitybefore surgeryStereoacuity measured at 40 cm using the Randot stereotests

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026