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Not yet recruiting NCT06656403

Effect of Artificial Tears on Ocular Biometry Parameters

No phase Interventional Dry Eye Disease Tear Film

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.1% sodium hyaluronate.
Who it may be relevant to
Registry conditions: Dry Eye Disease, Tear Film. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Drug 0.1% sodium hyaluronate
    After baseline measurement, 0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes

Primary outcome measures

  • flat meridian of the anterior corneal surface (K1) [Time frame: Baseline,30s,2min,5min]
  • steep meridian of the anterior corneal surface (K2) [Time frame: Baseline,30s,2min,5min]
  • central corneal thickness (CCT) [Time frame: Baseline,30s,2min,5min]
Secondary outcome measures (8)
  • axial length (AL) [Time frame: Baseline,30s,2min,5min]
  • corneal curvature radius(R1,R2) [Time frame: Baseline,30s,2min,5min]
  • anterior chamber depth (ACD) [Time frame: Baseline,30s,2min,5min]
  • white-to-white corneal diameter (WTW) [Time frame: Baseline,30s,2min,5min]
  • Pupil (Pup) [Time frame: Baseline,30s,2min,5min]
  • non-invasive tear break-up time (NITBUT) [Time frame: Baseline]
  • tear meniscus height(TMH) [Time frame: Baseline]
  • ocular surface disease index(OSDI) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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)
  • 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.
  • Any corneal lesions (corneal irregularity, corneal scar or corrosive burning, severe irregular astigmatism of cornea)
  • Fundus lesions (changes in the anatomical morphology of retinal macular fovea during axial length measurement, such as retinal detachment, edema, ulcer, etc.)
  • Patients with ocular trauma, surgery, and excessive photosensitivity, such as photodynamic therapy (PDT), were excluded.
  • using eye drops (0.1% Sodium hyaluronate) allergic patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 32828877
  • Nibandhe AS, Donthineni PR. Understanding and Optimizing Ocular Biometry for Cataract Surgery in Dry Eye Disease: A Review. Semin Ophthalmol. 2023 Jan;38(1):24-30. doi: 10.1080/08820538.2022.2112699. Epub 2022 Aug 20. PMID 35989638
  • Chen X, Yuan F, Wu L. Metaanalysis of intraocular lens power calculation after laser refractive surgery in myopic eyes. J Cataract Refract Surg. 2016 Jan;42(1):163-70. doi: 10.1016/j.jcrs.2015.12.005. PMID 26948792
  • Koh S. Irregular Astigmatism and Higher-Order Aberrations in Eyes With Dry Eye Disease. Invest Ophthalmol Vis Sci. 2018 Nov 1;59(14):DES36-DES40. doi: 10.1167/iovs.17-23500. PMID 30481804
  • Koh S, Tung CI, Inoue Y, Jhanji V. Effects of tear film dynamics on quality of vision. Br J Ophthalmol. 2018 Dec;102(12):1615-1620. doi: 10.1136/bjophthalmol-2018-312333. Epub 2018 Jun 15. PMID 29907632
  • 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. PMID 26432124
  • Sheard R. Optimising biometry for best outcomes in cataract surgery. Eye (Lond). 2014 Feb;28(2):118-25. doi: 10.1038/eye.2013.248. Epub 2013 Dec 6. PMID 24310239
  • 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. PMID 32982163

Identifiers

NCT: NCT06656403 · IOL2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗