Clinical trial NCT04443231: Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation
Official title: Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moderate and high myopia patients, underwent ICL implantation surgery at the Department of Ophthalmology, 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Retinal microvessels density
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 3 months postoperatively
measure: Mean refractive spherical equivalent
timeFrame: 3 months postoperatively
measure: Intraocular pressure
timeFrame: 3 months postoperatively
measure: Vault
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi, PhD, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.ophtha.2004.03.026.
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.
citation: 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.