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Visual outcomes of an enhanced monofocal intraocular lens targeted for monovision in highly myopic eyes: a randomized controlled trial

Visual outcomes of an enhanced monofocal intraocular lens targeted for monovision in highly myopic eyes: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108206
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Cataract

Interventions

Experimental group:Both eyes will be implanted with enhanced monofocal IOLs, with the dominant eye targeted for -0.5D and the nondominant eye for -2.0D.
Control group:Both eyes will be implanted with enhanced monofocal IOLs, with both eyes targeted for -2.0D.

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 to 85 years (including both age limits), no gender restrictions; 2.Both eyes had a surgical procedure scheduled for phacoemulsification with IOL implantation; 3.Bilateral axial length >= 26 mm; 4.There is a need for postoperative de-lenses; 5.Willing and able to complete all necessary follow-up visits and examinations and sign a informed consent form.

Exclusion criteria

Exclusion criteria: 1.Poor quality of preoperative ocular biometric measurements (axial length, corneal curvature, anterior chamber depth); 2.Preoperative corneal astigmatism >=1.5 D; 3.Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.); 4.The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.); 5.A history of intraocular surgery; 6.Severe chronic systemic diseases, psychiatric disorders, dementia, hearing impairments, or mobility issues that impair understanding of monovision design, completion of follow-up visits, or questionnaire completion.

Design outcomes

Primary

MeasureTime frame
Binocular uncorrected distance visual acuity at 4 m;

Secondary

MeasureTime frame
Photic phenomena;monocular and binocular defocus curves;Monocular and binocular uncorrected near visual acuity at 40cm;Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm;Spectacle independence;Stereoscopic vision;Monocular and binocular corrected distance visual acuity at 4 m;Binocular contrast sensitivity;Intraoperative or postoperative complications;Self-reported incidence and severity of ocular discomfort;Monocular and binocular uncorrected distance visual acuity at 4 m;Reading ability;Visual function;

Countries

China

Contacts

Public ContactLuo Lixia

The Zhongshan Ophthalmic Center,Sun Yat-sen University

luolixia@gzzoc.com+86 18665666679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026