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OpenTrials
Completed

NCT Number: NCT05207007

Visual Function in Pediatric Patients With Posterior Lens Opacities

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.

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Key information

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Visual acuity (BCVA)

    Time frame: 6 month after surgery

    Visual acuity (BCVA) measured by ETDRS chart after surgery

  2. Stereoacuity

    Time frame: 6 month after surgery

    Stereoacuity measured at 40 cm using the Randot stereotests

  3. modulation transfer function (MTF)

    Time frame: 6 month after surgery

    MTF measured with the Optical Quality Analysis System

  4. monochromatic aberrations

    Time frame: 6 month after surgery

    monochromatic aberrations measured by the iTrace Dynamic Laser Refraction

Secondary outcomes

  1. Location of the cataracts

    Time frame: before surgery

    divided into central, paracentral, and peripheral

  2. size of lens lesion

    Time frame: before surgery

    measured by image J

  3. Visual acuity (BCVA)

    Time frame: before surgery

    Visual acuity (BCVA) measured by ETDRS chart before surgery

  4. Stereoacuity

    Time frame: before surgery

    Stereoacuity measured at 40 cm using the Randot stereotests

  5. modulation transfer function (MTF)

    Time frame: before surgery

    MTF measured with the Optical Quality Analysis System

  6. monochromatic aberrations

    Time frame: before surgery

    monochromatic aberrations measured by the iTrace Dynamic Laser Refraction system

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2022
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.