Effect of Artificial Tears on Ocular Biometry Parameters
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHe Eye Hospital
About this trial
Due to the instability of the tear film, the biometry often needs to be done multiple times in a clinical environment. The high variability of both short-term and long-term repeatability in keratometry of dry eyes is well-known. Consequently, enhancing the condition of the eye surface in individuals with dry eyes will result in improved precision when choosing the power of intraocular lenses (IOLs). This prospective and before-and-after self-control study will recruit 100 patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
The eyes cannot fixate on the fixation lamp (such as children, nystagmus diseases, severe low vision, inattention, etc.) and cannot act according to the user's instructions and sit in the front of the equipment (the forehead or lower song is injured so that it cannot be supported on the forehead / lower song bracket)
The eyes are cloudy with optical media (such as corneal opacity, central corneal scar, mature cataract, posterior chamber bag opacity, vitreous hemorrhage, etc.).
The eyelid is completely closed or too small (drooping, relaxation) resulting in complete or partial occlusion of the cornea
Just after contact measurement or examination, use a corneal local anesthesia solution. (IOL Master 700 should avoid using local anesthetic before all contact examinations)
Trial design
Design model
Parallel
Treatments tested in this trial
0.1% sodium hyaluronate
DrugAfter baseline measurement, 0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Study groupOther 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
flat meridian of the anterior corneal surface (K1)
K1 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5min2
steep meridian of the anterior corneal surface (K2)
K2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5min3
central corneal thickness (CCT)
CCT was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5minSecondary outcomes
1
axial length (AL)
AL was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5min2
corneal curvature radius(R1,R2)
R1,R2 was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5min3
anterior chamber depth (ACD)
ACD was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5min4
white-to-white corneal diameter (WTW)
WTW was measured using IOL Master 700 for 4 times. To assess the Biometry measurements were assesssed at baseline, 2nd ,3rd and 4th(30-second, 2-minute and 5-minute intervals respectively) time after instilling one drop of ATD (0.1% Sodium hyaluronate, preservative free)
Time frame
Baseline,30s,2min,5minLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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