Study on the Effectiveness and Safety of Enhanced Monofocal Intraocular Lenses versus Standard Monofocal Intraocular Lenses for Intermediate Vision after Pediatric Cataract Surgery

Comparison of the Effectiveness and Safety of Enhanced Monofocal versus Standard Monofocal Intraocular Lenses for Intermediate Vision after Pediatric Cataract Surgery: A Prospective Cohort Study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600119057

Enrollment

Unknown

Registered

2026-02-14

Start date

2026-02-14

Completion date

Unknown

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cataract

Interventions

Standard Monofocal IOL Group:None

Enhanced IOL Group IOL:None

Eligibility

Sex/Gender

All

Age

4 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Standard Monofocal IOL Group :Aged 4–14 years; Diagnosed with monocular or binocular developmental/congenital cataract; Planned to undergo cataract extraction, implantation of standard monofocal intraocular lens (IOL), posterior capsulotomy, and anterior vitrectomy;Voluntarily agree to participate in this study and sign the informed consent form; Able to cooperate with follow-up examinations; 2.Enhanced IOL Group IOL :Aged 4–14 years; Diagnosed with monocular or binocular developmental/congenital cataract; Planned to undergo cataract extraction, implantation of enhanced monofocal intraocular lens (IOL), posterior capsulotomy, and anterior vitrectomy;Voluntarily agree to participate in this study and sign the informed consent form; Able to cooperate with follow-up examinations;

Exclusion criteria

Exclusion criteria: 1.Standard Monofocal IOL Group :Corneal astigmatism > 2.00 diopters (D); Complicated with other ocular diseases (including but not limited to glaucoma, macular lesions, corneal lesions, uveitis, retinal detachment, severe vitreous opacity, persistent fetal vasculature (PFV), or severe nystagmus); Complicated with systemic diseases: history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, or severe hepatic/renal dysfunction; Bilateral manifest strabismus, nystagmus, or any other pathological ocular changes or acute inflammatory ocular diseases; Previous history of ocular surgery; Currently participating in other clinical trials; 2.Enhanced IOL Group IOL :Corneal astigmatism > 2.00 diopters (D); Complicated with other ocular diseases (including but not limited to glaucoma, macular lesions, corneal lesions, uveitis, retinal detachment, severe vitreous opacity, persistent fetal vasculature (PFV), or severe nystagmus); Complicated with systemic diseases: history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, or severe hepatic/renal dysfunction; Bilateral manifest strabismus, nystagmus, or any other pathological ocular changes or acute inflammatory ocular diseases; Previous history of ocular surgery; Currently participating in other clinical trials;

Design outcomes

Primary

Measure	Time frame
distance-corrected intermediate visual acuity, DCIVA;	—

Secondary

Measure	Time frame
Contrast Sensitivity;Visual Disturbance Phenomena;Stereoscopic Vision;Defocus Curve;distance-corrected near visual acuity,DCNVA;Visual Axis Opacification(VAO);Abnormal Intraocular Pressure (IOP): > 21 mmHg or < 10 mmHg;Intraocular Lens (IOL) Decentration;corrected distance visual acuity,CDVA;	—

Countries

China

Contacts

Public ContactZhenzhen Liu

The Zhongshan Ophthalmic Center,Sun Yat-sen University

liuzhenzhen@gzzoc.com+86 135 7038 2241

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026