Balance in the Strabismic Patient Undergoing Strabismus Surgery
ConditionStrabismus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
Strabismus is a clinical condition characterized by the failure of the visual axes of the two eyes to align on the stared object. There are many possible causes of strabismus, but it can be divided into two main groups: concomitant strabismus, which is characterized by an almost equal angle of deviation in all positions of gaze, and incomitant or paralytic strabismus, which is characterized by a deficit of ocular motility in one or more directions of gaze. Depending on the age of onset, congenital strabismus and acquired strabismus are distinguished. Concomitant strabismus and incomitant strabismus can occur in both plastic age and adults. They are accompanied by diplopia or confusion if they arise in adulthood; there is no diplopia if they arise in plastic age due to cortical compensation mechanisms such as suppression or abnormal retinal matching. Causes of incomitant strabismus in adults can be: decompensation of a preexisting heterophoria; acute incomitant strabismus; injury to fusional centers. Paralytic incomitant strabismus is characterized by a reduction in the force developed by one or more muscles of an eye. Among incomitant strabismus, restrictive strabismus represent clinical pictures of very different etiology united by a single distinguishing feature: the existence of a mechanical obstacle to the free movement of the bulb in the orbit that prevents or reduces the excursion of the eye in one or more directions of gaze.
In about 4% of the young population, the sensory and/or motor pathways are not adequately developed, resulting in misalignment of the visual axes and strabismus. Eye surgery for strabismus is one of the most widely used treatment methods.
Only a few studies in the literature have analyzed changes in postural control after strabismus surgery and on a limited number of patients.
A French study evaluated the effect of surgery on postural control in children with strabismus, concluding that eye surgery affects the somatosensory properties of extraocular muscles, leading to improved postural control and that binocular visual perception could affect the whole body.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 16 and 65 years;
Presence of congenital strabismus or acquired strabismus in the care of the Ophthalmology OU, the Diagnosis and Treatment of Ocular Motility Disorders OU, and the Pediatric Ophthalmology Outpatient Clinic
Ability to maintain balance safely for at least 180 seconds;
In case of adult patient, Ability to understand and sign informed consent
Disqualifiers
Presence of diplopia associated with nystagmus;
Presence of psychomotor and cognitive delay, as assessed by the Mini Mental State Examination (adjusted score < 24);
Noncooperation of the patient;
Inability to provide informed consent, in the case of adult patients.
Trial population
Patients with strebismus, congenital or acquired, who will have surgery for surgical correction of strabismus during the study period will be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgery for strabismus
Procedure/SurgeryPatients will undergo surgery to correct strabismus, congenital or acquired
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: STR-CONG1 intervention
Group B: STR-ACQ1 intervention
Trial outcomes
Primary outcomes
1
Dynamic balance
Dynamic balance will be assessed using a robotic platform. Specifically, the reduction in the displacement of the center of pressure under dynamic conditions will be evaluated
Time frame
Change from Baseline Dynamic Balance at 30, 90 and 180 daysSecondary outcomes
1
Cover/Uncover test
It is a useful test to assess some characteristics of strabismus. It is always performed for both distance (6 m) and near (33 cm). The cover/uncover test is performed by occluding one of the two eyes with a screen for a few seconds and then uncovering it again allowing binocular vision, then performing the same maneuver on the other eye. Next, the alternating cover test is performed, which consists of covering first one eye and then the other with a screen, without allowing both eyes to see at the same time.
Time frame
Change from Baseline Cover/Uncover test at 30, 90 and 180 days2
Cover test with prisms
The test allows measurement of the angle of strabismus and is performed by sliding a slat of Berens prisms in front of either eye. The cover-test is repeated by sliding the prism bar and observing the amount of movement the deviated eye makes to take fixation. They will decrease, increasing the power of the prism, until they are cancelled. The prism that cancels the movement corresponds to the magnitude, in prism diopters, of the deviation angle.
Time frame
Change from Baseline Cover test with prisms at 30, 90 and 180 days3
Irvine test
The test consists of placing an externally based prism of 4 prism diopters in front of one eye. If there is convergence movement due to the disparity of image presentation to the two eyes, there is fusion movement, and if such movements are present for near (33 cm) and far (6 m and beyond), there is normal binocular vision. Otherwise, fusional motion will be absent.
Time frame
Change from Baseline Irvine test at 30, 90 and 180 days4
Angle measurement in the various positions of gaze
The method generally employed for this measurement is the screen test (cover test) in conjunction with a vertical or horizontal prism bar. Ocular deviation should be assessed in the following positions of gaze: * primary position, with head erect and looking straight ahead; * 4 secondary positions, are straight down, straight up, horizontally right and left; * 4 tertiary positions, are the oblique positions (up right and left, down right and left) Evaluation of these nine positions of gaze, referred to as diagnostic positions, provides a complete picture of alterations in the function of various muscles.
Time frame
Change from Baseline angle measurement at 30, 90 and 180 daysSponsors and contacts
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Source ClinicalTrials.gov