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Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04443231
Enrollment
25
Registered
2020-06-23
Start date
2018-11-01
Completion date
2019-10-01
Last updated
2020-06-23

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

Conditions

Adolescent, Adult, Female, Follow-up Studies, Human, Lens Implantation, Intraocular, Male, Myopia, Phakic Intraocular Lenses, Postoperative Period, Preoperative Period, Prospective Studies, Retinal Vessels, Tomography, Optical Coherence

Brief summary

To observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis.

Detailed description

The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was used to image the superficial and deep retinal vascular plexuses before ICL implantation surgery and at 3 months follow-up. OCTA images were corrected for magnification, skeletonized, separated the large vessels and partitioned. Retinal microvascular density was measured by using fractal dimension analysis. The aim of this study was to uncover potential retinal vascular network alterations induced by ICL implantation surgery.

Interventions

DEVICEOptical Coherence Tomography Angiography

AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 to 45 years old; * Binocular myopia, with a refraction of greater than -3 diopters (D); * anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) \> 2.8 mm; * corneal endothelial cell count (cECC) ≥ 2000 cells/mm2; * stable refraction at least 1 year before surgery; * unsatisfactory vision with contact lenses or spectacles.

Exclusion criteria

* history of intraocular surgery * other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.) * other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).

Design outcomes

Primary

MeasureTime frameDescription
Retinal microvessels density3 months postoperativelyRetinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)

Secondary

MeasureTime frameDescription
Best corrected visual acuity3 months postoperativelyBCVA was evaluated by decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
Mean refractive spherical equivalent3 months postoperativelyMRSE = Spherical power + 0.5 \* Cylindrical power
Intraocular pressure3 months postoperativelyThe IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).
Vault3 months postoperativelyThe central vault of the ICL (distance from posterior surface of ICL to the crystalline lens) was measured using Optical Coherence Tomography (Visante; Carl Zeiss Meditec, Jena, Germany)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026