Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Optical Coherence Tomography Angiography

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

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes