Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

NCT04443231 | Completed DMC

• 1 other identifier: tch0101
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Best corrected visual acuity

  3 months postoperatively

• Mean refractive spherical equivalent

  3 months postoperatively

• Intraocular pressure

  3 months postoperatively

• Vault

  3 months postoperatively

Interventions

Optical Coherence Tomography Angiography DEVICE

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (3)

• 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.

  PMID: 15350323 BACKGROUND

• 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.

  PMID: 27820633 RESULT

• 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.

  PMID: 27818204 RESULT

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Hong Qi, PhD, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: June 23, 2020
• Study Start: November 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 23, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)