Visual Function in Pediatric Patients With Posterior Lens Opacities

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Cataract Polar Posterior

Intervention / Treatment
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* Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| posterior polar cataracts<br>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<br>* Phacomulsification lens removal cataract surgery with IOL implantation in both two groups<br>|
| posterior lenticonus<br>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<br>* Phacomulsification lens removal cataract surgery with IOL implantation in both two groups<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual function, posterior polar cataracts, posterior lenticonus