Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Completed

• Conditions: Prospective Studies; Myopia; Adolescent; Postoperative Period; Human; Female; Phakic Intraocular Lenses; Tomography, Optical Coherence; Adult; Male

• Registration Number: NCT04443231
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-07
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-22
• Study First Posted: 2020-06-23
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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.).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retinal microvessels density	3 months postoperatively	Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	3 months postoperatively	The IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).
Vault	3 months postoperatively	The 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)
Best corrected visual acuity	3 months postoperatively	BCVA was evaluated by decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
Mean refractive spherical equivalent	3 months postoperatively	MRSE = Spherical power + 0.5 \* Cylindrical power

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China