Functional changes in the visual cortex in preoperative and postoperative patients with intermittent exotropia: study protocol for a non-randomised case–control clinical trial

Abstract

IntroductionIntermittent exotropia (IXT) is the most common type of divergent squint. IXT is primarily a cortical neurologic dysfunction disorder, occurring as a result of the insufficient maintenance of sensory and motor fusion. Recent reports have demonstrated the relationship between IXT and visual cortical impairment. We planned to assess blood oxygen level-dependent (BOLD)-functional magnetic resonance imaging (fMRI) in patients with IXT during the preoperative and postoperative follow-ups to evaluate the functional changes in the visual cortex.Methods and analysisA total of 90 Chinese subjects will be recruited, and their ages will be between 18 and 40 years old. The subjects will include the surgical treatment (ST) group (45 subjects with IXT who will undergo surgery) and the HC group (45 age-matched, sex-matched and education-matched healthy volunteers). The assessments will include the following aspects: fMRI and general ophthalmic examinations, optometry measurements and strabismus-related tests, such as the ocular deviation, binocular vision test and Newcastle Control Score (NCS). Each subject will complete the resting-state BOLD-fMRI, and the sequences will include echo planar imaging (EPI) pulse and 3-dimensional brain volume (3D-BRAVO) to acquire high-resolution images. The follow-up schedule will be 6 and 12 months after the surgery. The primary outcome will be determined by cortex changes in BOLD-fMRI in the ST group before and after surgery. We will also compare the HC group with the preoperative subjects in the ST group. The secondary outcomes will be changes in strabismus-related examinations, such as binocular visual function and NCS.Ethics and disseminationEthical approval was obtained from the Medical Ethics Committee of Beijing Tongren Hospital. We plan to publish the results of this study in a peer-reviewed journal article.Trial registration numberChiCTR2100048852