Clinical trial NCT05207007: Visual Function in Pediatric Patients With Posterior Lens Opacities
Official title: Visual Function in Pediatric Patients With Posterior Polar Cataracts and Posterior Lenticonus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cataract Polar Posterior
Keywords: visual function
posterior polar cataracts
posterior lenticonus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual acuity (BCVA)
timeFrame: 6 month after surgery
measure: Stereoacuity
timeFrame: 6 month after surgery
measure: modulation transfer function (MTF)
timeFrame: 6 month after surgery
measure: monochromatic aberrations
timeFrame: 6 month after surgery
Secondary outcomes:
measure: Location of the cataracts
timeFrame: before surgery
measure: size of lens lesion
timeFrame: before surgery
measure: Visual acuity (BCVA)
timeFrame: before surgery
measure: Stereoacuity
timeFrame: before surgery
measure: modulation transfer function (MTF)
timeFrame: before surgery
measure: monochromatic aberrations
timeFrame: before surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Weirong Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: