Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04443231

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	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 Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Outcome Measures

Primary Outcome Measures

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

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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	Beijing	China	100191

Sponsors and Collaborators

Peking University Third Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04443231

Other Study ID Numbers:

tch0101

First Posted:

Jun 23, 2020

Last Update Posted:

Jun 23, 2020

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Jun 23, 2020