Effect of Artificial Tears on Ocular Biometry Parameters

NCT06656403 | Not Yet Recruiting

• 1 other identifier: IOL2024
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Disease; Tear Film

Keywords

dry eye; IOL Master 700; tear film

Outcome Measures

Primary Outcomes (3)

• 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)

  Baseline,30s,2min,5min

• 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)

  Baseline,30s,2min,5min

• 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)

  Baseline,30s,2min,5min

Secondary Outcomes (8)

• axial length (AL)

  Baseline,30s,2min,5min

• corneal curvature radius(R1,R2)

  Baseline,30s,2min,5min

• anterior chamber depth (ACD)

  Baseline,30s,2min,5min

• white-to-white corneal diameter (WTW)

  Baseline,30s,2min,5min

• Pupil (Pup)

  Baseline,30s,2min,5min

Study Arms (2)

Study group

OTHER

dry eye patients

Drug: 0.1% sodium hyaluronate

Control group

OTHER

non-dry eye patients

Drug: 0.1% sodium hyaluronate

Interventions

0.1% sodium hyaluronate DRUG

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

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• He Eye Hospital: lead

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Sahin A, Hamrah P. Clinically relevant biometry. Curr Opin Ophthalmol. 2012 Jan;23(1):47-53. doi: 10.1097/ICU.0b013e32834cd63e.

  PMID: 22081032 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Guanghao Qin

  He Eye Specialist Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanghao Qin

CONTACT

+86-18842664420; qinguanghao2020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: October 30, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 21, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10