Effect of Artificial Tears on Ocular Biometry Parameters

NCT ID: NCT06656403

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2024-11-21

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).

Conditions

Dry Eye Disease; Tear Film

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Study group

dry eye patients

Group Type: OTHER

0.1% sodium hyaluronate

Intervention Type: DRUG

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

Control group

non-dry eye patients

Group Type: OTHER

0.1% sodium hyaluronate

Intervention Type: DRUG

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

Interventions

0.1% sodium hyaluronate

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

He Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guanghao Qin

Role: PRINCIPAL_INVESTIGATOR

He Eye Specialist Hospital

Central Contacts

Guanghao Qin

Role: CONTACT

qinguanghao2020@163.com

+86-18842664420

References

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Reference Type: BACKGROUND

PMID: 32828877 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35989638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26948792 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30481804 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 29907632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26432124 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24310239 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32982163 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 22081032 (View on PubMed)

Other Identifiers

IOL2024

Identifier Type: -

Identifier Source: org_study_id