Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury With Optical Coherence Tomography
Conditions: Eye Injury Trauma
Sponsor: Akdeniz University

 
Study Protocol and Statistical Analysis Plan  
 
Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury  
 
NCT05771467  
 
November 27, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objective: To evaluate the effect of open globe injury on anterior chamber, intraocular 
pressure measurements, retina and choroidal microvascular circulation in the unaffected 
eye; and to compare results among healthy age-matched individuals.  
 
Methods: This prospective case-control study was approved by the local ethics committee 
of the Akdeniz University Faculty of Medicine (Approval Number: 2021-162) and the study 
was conducted in compliance with the ethical standards set out in the Declaration of 
Helsinki. Informed consent was obtained from the participants who agreed to participate in 
the study. All subjects underwent a comprehensive ophthalmologic examination, which 
included refractive error (Nidek ARK-700A, Nidek Co., Ltd, Gamagori, Japan), best 
corrected visual acuity (BCVA), IOP/Fully Automatic Tonometer, NIDEK NT-2000, Nidek 
Co., Ltd., Aichi, Japan), biometry and axial length (AL) (IOLMASTER 500, Carl Zeiss 
Meditec AG, Jena, Germany), slit-lamp examination of the anterior and posterior segments, 
Scheimflug Topography (Pentecam Oculus Optikgeräte GmbH, Wetzlar, Germany), and 
retinal and choroidal thickness and microvascular circulation of the retina and choroid were 
measured and recorded with Swept-Source Optical Coherence Tomography Angio™ 
(Topcon Corp, Japan). The BCVA was converted into the logarithm of minimal angle 
resolution (logMAR). Of the individuals included in the study, anterior chamber depth 
(ACD), anterior chamber volume (ACV), central corneal thickness (CCT), thinnest corneal 
thickness (TCT), astigmatism value (AST), corneal volume (CV), axial length (AL), 
spherical equivalent (SFEQ), intraocular lens power (ILP), VA (visual acuity), central 
retinal thicness (CRT), central choroidal thickness (CCT), superficial retinal circulation 
(SRC), deep retinal circulation (DRC) and choriocapillaris circulation (CC) data were 
recorded. The patients were followed for approximately six months, examined at one week, 
one month and three months after the trauma, and a total of three measurements were taken 
from the subjects. One measurement was taken from the control group.  
 
Statistical Analysis Plan (SAP): Statistical analyzes were performed using the IBM SPSS 
package, version 23.0 (SPSS Inc., Chicago, IL, USA). The Shapiro-Wilk test was used to 
analyze the normality of sample distribution. To define the sample, normally distributed 
values are presented as means ± standard deviation, and non-normally distributed values are 
presented as median (minimum–maximum). The two-way repeated measures ANOVA test 
was used to examine the time-dependent change of the data. For the analysis of independent 
data, the independent-sample t-test and Mann-Whitney U test were used. For the analysis of 

correlation, Spearman's correlation coefficient was used. The results were evaluated at a 
95% CI. A level of p<0.05 was accepted as statistically significant.