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NCT Number: NCT06656403

Effect of Artificial Tears on Ocular Biometry Parameters

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1% sodium hyaluronate

Drug

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

Primary outcomes

  1. flat meridian of the anterior corneal surface (K1)

    Time frame: Baseline,30s,2min,5min

    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)

  2. steep meridian of the anterior corneal surface (K2)

    Time frame: Baseline,30s,2min,5min

    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)

  3. central corneal thickness (CCT)

    Time frame: Baseline,30s,2min,5min

    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)

Secondary outcomes

  1. axial length (AL)

    Time frame: Baseline,30s,2min,5min

    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)

  2. corneal curvature radius(R1,R2)

    Time frame: Baseline,30s,2min,5min

    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)

  3. anterior chamber depth (ACD)

    Time frame: Baseline,30s,2min,5min

    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)

  4. white-to-white corneal diameter (WTW)

    Time frame: Baseline,30s,2min,5min

    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)

  5. Pupil (Pup)

    Time frame: Baseline,30s,2min,5min

    Pup 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)

  6. non-invasive tear break-up time (NITBUT)

    Time frame: Baseline

    Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded

  7. tear meniscus height(TMH)

    Time frame: Baseline

    TMH using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded

  8. ocular surface disease index(OSDI)

    Time frame: Baseline

    Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points

Study contacts

Contact information is provided by the study sponsor or research team.

Guanghao Qin

CONTACT

[email protected]

+86-18842664420

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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