Highlight
• The CLEVR‑PCG randomized clinical trial found that rigid gas‑permeable contact lenses (RGPCLs) produced superior visual outcomes compared with continued spectacle correction in children after primary congenital glaucoma (PCG) surgery over 12 months.
• The RGPCL arm achieved an adjusted mean improvement in worse‑eye BCVA of 0.31 versus 0.12 logMAR (adjusted treatment difference −0.19 logMAR; 95% CI −0.36 to −0.02; P = .03), equivalent to roughly 2 Snellen lines (≈10 letters).
• Secondary benefits included greater gains in contrast sensitivity and near stereoacuity; no serious adverse events were reported.
Background: clinical context and unmet need
Primary congenital glaucoma (PCG) is a developmental optic neuropathy presenting in infancy or early childhood and is a leading cause of childhood blindness in many settings. Surgical management (eg, goniotomy, trabeculotomy, trabeculectomy, or combined procedures) aims to control intraocular pressure (IOP) and preserve the structural integrity of the anterior segment and optic nerve. However, operated eyes frequently retain significant refractive error (high myopia, astigmatism, anisometropia) and irregular corneal shape after surgery. These optical problems, together with the high amblyopia risk in early life, mean that visual rehabilitation and optical correction are crucial for long-term functional outcome.
Spectacles are the default correction in many settings but may be insufficient in high ametropia, irregular corneal optics, or when spectacles cause excessive aniseikonia or optical distortion. Rigid gas‑permeable contact lenses can neutralize corneal irregularity with a tear lens, reduce higher‑order aberrations, and provide a more uniform optical surface, potentially improving acuity, contrast sensitivity, and binocular function. Robust randomized data comparing RGPCLs with spectacles after PCG surgery have been lacking until the CLEVR‑PCG trial.
Study design
CLEVR‑PCG was a single‑center randomized clinical trial conducted at Zhongshan Ophthalmic Center, Guangzhou, China, between April 21, 2022, and August 21, 2023. The trial enrolled children aged 4–15 years who had undergone surgery for PCG and had poor response to spectacles. Participants were randomized to receive RGPCLs (n = 29) versus continued spectacle wear (n = 27) for 12 months; all participants received standardized amblyopia patching as indicated.
The primary outcome was change in worse‑eye best‑corrected visual acuity (BCVA) at 12 months measured by ETDRS tumbling‑E charts (logMAR). Key secondary outcomes included contrast sensitivity function and near stereoacuity. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2100043776).
Key findings
Participants and follow-up
Of 83 children screened, 56 were randomized; 48 (85.7%) completed at least one follow‑up and were included in the primary analysis. At 12 months, 22 of 29 (76.0%) in the RGPCL arm and 19 of 27 (70.4%) in the spectacle arm completed the final visit. Baseline characteristics were broadly similar: mean age roughly 7–8 years, predominantly male in both arms, mean baseline worse‑eye BCVA approximately 1.0 logMAR (≈20/200), and baseline worse‑eye spherical equivalent averaging −6.55 D in the RGPCL arm versus −5.17 D in the spectacles arm.
Primary outcome: visual acuity
After 12 months, the RGPCL group experienced greater mean improvement in worse‑eye BCVA compared with the spectacles group: mean (SD) improvement 0.31 (0.28) versus 0.12 (0.33) logMAR. The adjusted treatment difference was −0.19 logMAR (95% CI −0.36 to −0.02; P = .03), approximately equivalent to a 10‑letter improvement on an ETDRS chart (nearly 2 Snellen lines). Achievement of two or more lines (≥0.2 logMAR) of BCVA improvement occurred in 62.5% (15/24) in the RGPCL arm versus 37.5% (9/24) in the spectacle arm (odds ratio 6.83; 95% CI 1.81–25.73; P = .01).
Secondary outcomes: contrast sensitivity and stereoacuity
Contrast sensitivity function improved more in the RGPCL group (mean change 0.40 [0.27]) versus spectacles (0.13 [0.32]); the adjusted treatment difference was 0.24 log units (95% CI −0.01 to 0.49; P = .04), indicating clinically relevant gains in mid‑to‑low contrast vision. Near stereoacuity of ≤60 arcseconds was achieved by 50.0% (12/24) in the RGPCL arm versus 25.0% (6/24) in the spectacles arm (odds ratio 6.96; 95% CI 2.41–6.51; P = .001), suggesting improved binocular function in the contact lens group.
Safety
No serious adverse events were reported. The trial notes no treatment‑limiting safety signals across the 12‑month follow‑up. Routine contact lens risks (microbial keratitis, corneal staining) were not reported as serious in this cohort but remain important considerations in clinical practice.
Interpretation and clinical implications
The CLEVR‑PCG trial provides randomized evidence that RGPCLs confer superior visual rehabilitation compared with spectacles for children after PCG surgery who have suboptimal spectacle response. The magnitude of benefit—an adjusted −0.19 logMAR improvement in the worse eye—translates to clinically meaningful gains (≈2 lines on an ETDRS chart). Improvements in contrast sensitivity and near stereoacuity strengthen the functional relevance of the acuity gains, because contrast and stereoacuity relate directly to everyday visual tasks and binocular integration.
Mechanistically, RGPCLs can mask corneal irregularities and provide a stable refractive surface and tear lens that reduce higher‑order aberrations. In eyes with high anisometropia or irregular corneas after PCG surgery, spectacles can produce optical blur, peripheral distortion, and aniseikonia that limit acuity and binocular function; RGPCLs reduce these optical penalties.
From a practice standpoint, the trial supports earlier consideration of RGPCLs in the postoperative optical management of PCG, particularly for children with poor spectacle tolerance or persistent visual deficits despite amblyopia therapy. Implementation requires access to experienced contact lens fitting services, caregiver engagement for lens care, and monitoring for lens‑related complications.
Expert commentary and limitations
Strengths of CLEVR‑PCG include randomized design, clinically relevant outcomes (ETDRS acuity, contrast sensitivity, stereoacuity), and standardized amblyopia therapy across arms. The observed benefits were consistent across acuity and functional measures, arguing for a real treatment effect rather than measurement artifact.
Limitations and considerations:
- Single‑center design: Zhongshan Ophthalmic Center is a tertiary referral institution with experienced pediatric contact lens services; generalizability to resource‑limited settings or centers without specialized contact lens clinics may be limited.
- Sample size and follow-up: The trial randomized 56 children with 12‑month follow‑up; longer follow‑up is needed to determine durability of gains and longer‑term safety (eg, infection risk with extended wear, corneal endothelial effects).
- Selection criteria: Participants were aged 4–15 years and had poor spectacle response. Results may not apply to younger infants or to children who respond well to spectacles.
- Adherence and caregiver burden: Successful RGPCL use in children requires caregiver commitment to insertion, removal, disinfection, and monitoring; trial results reflect an adherence‑supported environment and may overestimate outcomes in less supported contexts.
- Cost and access: Contact lens fitting, specialized lenses, and follow‑up entail costs that may limit patient access; cost‑effectiveness analyses are needed.
These caveats notwithstanding, the study fills an important evidence gap and provides randomized data in a clinically important population.
Practical recommendations for clinicians
For children after PCG surgery with suboptimal visual outcomes on spectacles, consider the following approach informed by CLEVR‑PCG:
- Early optical assessment after IOP stabilization and corneal healing to quantify refractive error, corneal topography, and higher‑order aberrations.
- Trial of RGPCL fitting when spectacles are inadequate (poor acuity, intolerance, high anisometropia, irregular cornea) and when caregivers can support lens care.
- Integrate RGPCL correction with standardized amblyopia therapy (patching or penalization) and scheduled monitoring for lens fit, corneal health, and visual development.
- Educate families about benefits, insertion/removal technique, hygiene, follow‑up schedule, and signs of contact lens complications.
Conclusion
The CLEVR‑PCG randomized trial demonstrates that RGPCLs yield superior visual acuity, contrast sensitivity, and near stereoacuity compared with continued spectacle wear in children after PCG surgery who have poor spectacle response. These findings support incorporation of RGPCLs into postoperative visual rehabilitation pathways for appropriate patients, subject to availability of fitting expertise and caregiver support. Further multicenter trials and longer‑term follow‑up would help define durability, safety, and cost‑effectiveness across diverse healthcare settings.
Funding and trial registration
Trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR2100043776.
References
1. Jiang J, Hu Y, Zhu Y, et al. Visual Outcomes of Children With Primary Congenital Glaucoma Receiving Different Refractive Corrections: The CLEVR‑PCG Randomized Clinical Trial. JAMA Ophthalmol. 2025 Nov 6. doi:10.1001/jamaophthalmol.2025.3976. PMID: 41196588.
2. American Academy of Ophthalmology Pediatric Ophthalmology/Strabismus Panel. Pediatric Ophthalmology/Strabismus Preferred Practice Pattern. San Francisco, CA: American Academy of Ophthalmology; last revised 2017.
Author note
This summary was prepared by a clinical medical writer synthesizing the CLEVR‑PCG randomized clinical trial and placing it in the context of pediatric visual rehabilitation. Clinical decisions should be individualized and made in consultation with pediatric ophthalmology and contact lens specialists.
