JAMA Ophthalmology | RCT Study by Team of Prof. YANG Xiao and Prof. LIU Xing on Visual Rehabilitation in Congenital Glaucoma: Contact Lenses Significantly Improve Children's Visual Function

Origin：Prof. Yang Xiao / Prof. Liu Xing's Team, Office of Science and Technology

Author：Jiang Jinyun, Hu Yin

Editor：Liu Te

Published：2025-12-20

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Primary Congenital Glaucoma (PCG) is one of the leading causes of childhood blindness. Surgery is the primary treatment to lower intraocular pressure (IOP) and protect the optic nerve. However, children with well-controlled postoperative IOP often still face significant visual challenges. Previous studies have shown that only about 30% of children with PCG achieve favorable corrected visual acuity during long-term follow-up. Among the main contributing factors are corneal irregularities caused by eyeball enlargement, significant refractive errors (such as high astigmatism and anisometropia), and subsequent amblyopia.

01. Study Background

Traditional spectacles are often insufficient to correct complex higher-order aberrations and irregular astigmatism in children with PCG after surgery. In contrast, Rigid Gas Permeable Contact Lenses (RGPCLs) can form a tear lens on the ocular surface, offering unique advantages in terms of optical principles and theoretically delivering superior visual quality. However, current evidence-based data regarding the application of RGPCLs in children with PCG remains limited, with a lack of high-quality randomized controlled trials (RCTs) evaluating the long-term efficacy and safety.

To address this clinical challenge, a team led by Professor YANG Xiao from the Department of Refraction and Adolescent Myopia Control, together with a team led by Professor LIU Xing from the Department of Glaucoma, both at Zhongshan Ophthalmic Center, Sun Yat-sen University, conducted a prospective, single-center, randomized controlled clinical trial. This study aimed to compare the efficacy and safety of RGPCLs versus traditional spectacles in the visual rehabilitation of children with PCG after surgery, providing high-quality clinical evidence for visual rehabilitation in this special population.

02. Study Details

The study enrolled 56 children aged 4-15 with PCG who had stable IOP control after surgical treatment but showed poor response to spectacle correction. They were randomly assigned to either an RGPCL group or a continued spectacle-wearing group, combined with standard occlusion therapy, and followed for 12 months.

1) RGPCL Group Showed Significantly Greater Visual Acuity Improvement Than Spectacle Group

The primary outcome measure of the study was the change in best-corrected visual acuity (BCVA) of the worse eye. Results showed that at the end of the 12-month follow-up, the magnitude of visual acuity improvement in the RGPCL group was significantly greater than that in the spectacle group. The RGPCL group achieved an average improvement of 0.31 logMAR (approximately 3 lines), while the spectacle group improved by only 0.12 logMAR (approximately 1 line). In terms of clinically significant visual acuity improvement (defined as an improvement of 2 lines or more), 62.5% of children in the RGPCL group met this criterion, significantly higher than the 37.5% in the spectacle group. This indicates that for children with suboptimal postoperative visual acuity, RGPCLs can provide more effective visual rehabilitation.

Figure 1: Rate of visual acuity improvement in the worse-seeing eye (A) and better-seeing eye (B) for the RGPCL group vs. the spectacle group

2) RGPCL Group Demonstrated Superior Improvement in Stereopsis and Contrast Sensitivity

The study’s secondary outcome measures focused on the quality of visual function. The RGPCL group showed superior improvements in both contrast sensitivity function (CSF) and near stereopsis. Data indicated that the area under the log contrast sensitivity function curve (AULCSF) increased by an average of 0.40 log units in the RGPCL group, significantly better than the 0.13 log units in the spectacle group. Regarding stereopsis, after 12 months of follow-up, the proportion of children with good near stereopsis (≤60 arcseconds) in the RGPCL group increased from 21% at baseline to 50%, while it only increased from 21% to 25% in the spectacle group. This suggests that RGPCLs not only provide better visual acuity correction but also help children develop better binocular vision, which is crucial for their daily activities and visual development.

Figure 2: Distribution of near stereopsis at baseline and 12-month follow-up for the RGPCL group (A) and the spectacle group (B)

3) RGPCL Wear Demonstrated Good Safety Profile with No Serious Adverse Events

Regarding the safety of contact lenses, a common concern for parents, the study results were reassuring. During the one-year follow-up, no serious ocular adverse events were reported in the RGPCL group. Although careful lens care by parents/children and regular follow-up examinations are required, the study confirmed that with proper management, RGPCLs are a safe vision correction method for children with PCG after surgery.

This study is one of the few high-quality RCTs in the field of visual rehabilitation for children with congenital glaucoma after surgery. The results strongly confirm that for children with PCG who have poor postoperative vision or poor adaptation to spectacles, RGPCLs can provide superior visual acuity improvement, contrast sensitivity enhancement, and stereopsis restoration compared to spectacles. This finding offers new clinical guidance for the postoperative management of children with PCG, suggesting that ophthalmologists should consider initiating visual rehabilitation therapy earlier and more proactively while focusing on IOP control, to maximize the visual development of affected children.

03. Research Team

The above research results were recently published online in JAMA Ophthalmology (CAS Tier 1), an authoritative ophthalmology journal. Professor YANG Xiao from Zhongshan Ophthalmic Center, Sun Yat-sen University, is the corresponding senior author, and Professor LIU Xing is the co-corresponding author. Postdoctoral fellow JIANG Jinyun, Associate Chief Physician HU Yin, and Associate Chief Physician ZHU Yingting are the co-first authors.

1) Corresponding Authors