Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Myopia Clinical Trial

Official title:

Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443231
• Other study ID #: tch0101
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.).

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mean refractive spherical equivalent	MRSE = Spherical power + 0.5 * Cylindrical power	3 months postoperatively
Secondary	Intraocular pressure	The IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).	3 months postoperatively
Secondary	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