Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

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.

Study Overview

• Status: Completed
• Conditions: Adolescent; Myopia; Female; Adult; Male; Preoperative Period; Lens Implantation, Intraocular; Tomography, Optical Coherence; Postoperative Period; Human; Prospective Studies; Follow-up Studies; Phakic Intraocular Lenses; Retinal Vessels
• Intervention / Treatment: Device: Optical Coherence Tomography Angiography

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Moderate and high myopia patients, underwent ICL implantation surgery at the Department of Ophthalmology, Peking University Third Hospital

Description

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.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Hong Qi, PhD, MD, Peking University Third Hospital

Publications and helpful links

General Publications

• Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004 Sep;111(9):1683-92. doi: 10.1016/j.ophtha.2004.03.026.
• Yang Y, Wang J, Jiang H, Yang X, Feng L, Hu L, Wang L, Lu F, Shen M. Retinal Microvasculature Alteration in High Myopia. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6020-6030. doi: 10.1167/iovs.16-19542.
• Li M, Yang Y, Jiang H, Gregori G, Roisman L, Zheng F, Ke B, Qu D, Wang J. Retinal Microvascular Network and Microcirculation Assessments in High Myopia. Am J Ophthalmol. 2017 Feb;174:56-67. doi: 10.1016/j.ajo.2016.10.018. Epub 2016 Nov 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: tch0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No