Clinical trial NCT06656403: Effect of Artificial Tears on Ocular Biometry Parameters
Official title: Effect of Artificial Tears on Ocular Biometry Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Tear Film
Keywords: dry eye
IOL Master 700
tear film
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Over the past ten years, surgery has progressed from rejuvenation surgery to refractive surgery, which focuses on enhancing both vision and addressing pre-existing issues that impact visual quality. This is why good surgical outcomes involve thorough preoperative assessment and precise intraocular lens(IOL) power determination. To achieve the intended postoperative refractive outcomes, it is essential to perform an accurate calculation of intraocular lens power (i.e., biometry), which may impact the accuracy of the computation.

Damage to the eye's surface from chronic inflammation and induced tear film hyperosmolarity occurs in DED because tear film homeostasis is disrupted. The changes in tear film dynamics and damage to the ocular surface result in mistakes in optical measures, which in turn affect the results of procedures like cataract surgery that heavily rely on these assessments.

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).

Eligibility criteria: Inclusion Criteria:

(1) age ≥18 years,(2) able and willing to comply with the treatment schedule.

Exclusion Criteria:

1. 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)
2. The eyes are cloudy with optical media (such as corneal opacity, central corneal scar, mature cataract, posterior chamber bag opacity, vitreous hemorrhage, etc.).
3. The eyelid is completely closed or too small (drooping, relaxation) resulting in complete or partial occlusion of the cornea
4. Just after contact measurement or examination, use a corneal local anesthesia solution. (IOL Master 700 should avoid using local anesthetic before all contact examinations)
5. Tear film deformation (lack of specular reflection of the cornea during corneal curvature measurement), the severity of grade IV dry eye, and whether eye drops were used 24 hours before the examination.
6. Any corneal lesions (corneal irregularity, corneal scar or corrosive burning, severe irregular astigmatism of cornea)
7. Fundus lesions (changes in the anatomical morphology of retinal macular fovea during axial length measurement, such as retinal detachment, edema, ulcer, etc.)
8. Patients with ocular trauma, surgery, and excessive photosensitivity, such as photodynamic therapy (PDT), were excluded.
9. using eye drops (0.1% Sodium hyaluronate) allergic patients

Primary outcomes:
measure: flat meridian of the anterior corneal surface (K1)
timeFrame: Baseline,30s,2min,5min
measure: steep meridian of the anterior corneal surface (K2)
timeFrame: Baseline,30s,2min,5min
measure: central corneal thickness (CCT)
timeFrame: Baseline,30s,2min,5min
Secondary outcomes:
measure: axial length (AL)
timeFrame: Baseline,30s,2min,5min
measure: corneal curvature radius(R1,R2)
timeFrame: Baseline,30s,2min,5min
measure: anterior chamber depth (ACD)
timeFrame: Baseline,30s,2min,5min
measure: white-to-white corneal diameter (WTW)
timeFrame: Baseline,30s,2min,5min
measure: Pupil (Pup)
timeFrame: Baseline,30s,2min,5min
measure: non-invasive tear break-up time (NITBUT)
timeFrame: Baseline
measure: tear meniscus height(TMH)
timeFrame: Baseline
measure: ocular surface disease index(OSDI)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: He Eye Specialist Hospital
name: Guanghao Qin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.
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citation: Epitropoulos AT, Matossian C, Berdy GJ, Malhotra RP, Potvin R. Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning. J Cataract Refract Surg. 2015 Aug;41(8):1672-7. doi: 10.1016/j.jcrs.2015.01.016.
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citation: Hovanesian J, Epitropoulos A, Donnenfeld ED, Holladay JT. The Effect of Lifitegrast on Refractive Accuracy and Symptoms in Dry Eye Patients Undergoing Cataract Surgery. Clin Ophthalmol. 2020 Sep 16;14:2709-2716. doi: 10.2147/OPTH.S264520. eCollection 2020.
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