Effect of Artificial Tears on the Parameters of the Eye and Its Impact on IOL Power Calculation for Cataract Surgery (IOL)

January 10, 2021 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

Effect of Artificial Tears on the Parameters of the Eye in Normal and Dry Eyes and Its Impact on IOL Power Calculation for Cataract Surgery

First, preoperative biometry of the eye at the IOL Master® will be performed. Then, corneal topography will be measured at the Oculus pentacam®. Afterwards, one of two eye drops are instilled in the eye, and biometry and corneal topography will be repeated after 5 minutes.

For all patients, the Barrett Universal II formula will be used for calculation of IOL power. Predicted refraction outcome will be referred to as SEQ. The chief surgeon will perform the uneventful standard cataract operation with in-the-bag implantation of a HOYA IOL (Model 251) through a 2.4-mm corneal incision.

A Subjective Refraction using plus principle will be performed one month after the operation, and ETDRS visual acuity charts will be used to measure best-corrected visual acuity. Refraction will be described as SR (postoperative SEQ) and will be calculated as:

SR = sphere + (0.5*cylinder)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

First, preoperative biometry of the eye at the IOL Master® will be performed. Then, corneal topography will be measured at the Oculus pentacam®. Patients will be classified as dry eye or normal eye based on BUT. The tear film breakup (BUT) time of less than 5 seconds will be diagnosed as dry eyes.Afterwards, one of two eye drops are instilled in the eye, and biometry and corneal topography will be repeated after 5 minutes.

For all patients, the Barrett Universal II formula will be used for calculation of IOL power. Predicted refraction outcome will be referred to as SEQ. The chief surgeon will perform the uneventful standard cataract operation with in-the-bag implantation of a HOYA IOL (Model 251) through a 2.4-mm corneal incision.

A Subjective Refraction using plus principle will be performed one month after the operation, and ETDRS visual acuity charts will be used to measure best-corrected visual acuity. Refraction will be described as SR (postoperative SEQ) and will be calculated as:

SR = sphere + (0.5*cylinder)

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A patient diagnosed with age related cataract
  • 30 to 95 years old
  • Medical history and physical examination should be normal.

Exclusion Criteria:

  • • Abnormality of the cornea (scaring of the cornea)

    • If any topical therapy (i.e. glaucoma) of the eye is needed
    • Active allergy of eye or nose
    • Any conjunctivitis or keratitis
    • If nasolacrimal drainage apparatus is abnormal
    • severity level 4 of dry eye (constant discomfort in the eye accompanied with visual symptoms, filamentary keratitis, , keratinization, severe conjunctival injection, ulceration clumping of mucus glands, tear debris, , trichiasis, symblepharon)
    • deformities of lid
    • Preceding eye trauma or surgery
    • Any Uncontrolled ocular disease or systemic disease
    • Lactation
    • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: sodium hyaluronate 0.1%
First preoperative Biometry of the eye at the IOL Master® will be measured. Then, corneal topography will be measure at the Oculus pentacam®. Afterwards, sodium hyaluronate 0.1% will be installed and biometry and corneal topography will be repeated after 5 minutes.
Device: sodium hyaluronate 0.1%
Instillation of one drop sodium hyaluronate 0.1%
ACTIVE_COMPARATOR: sodium hyaluronate 0.3%
First preoperative Biometry of the eye at the IOL Master® will be measured. Then,corneal topography will be measure at the Oculus pentacam®. Afterwards, sodium hyaluronate 0.3% will be installed and biometry and corneal topography will be repeated after 5 minutes.
Device: sodium hyaluronate 0.3%
Instillation of one drop sodium hyaluronate 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
keratometric value of the eye measured with Master 500 before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
k-value (k, k1, k2 in Diopter)
5 minutes
Axial length of the eye measured with Master 500 before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
Axial length (AL in mm)
5 minutes
Anterior chamber depth of the eye measured with Master 500 before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
Anterior chamber depth (ACD in mm)
5 minutes
Sim K of the eye measured with Oculus Pentacam before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
Sim K (k1, k2 in Diopter)
5 minutes
Total Corneal Refractive Power of the eye measured with Oculus Pentacam before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
Total Corneal Refractive Power (TCRP in Diopter),
5 minutes
Total Corneal Irregular Astigmatism of the eye measured with Oculus Pentacam before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
Total Corneal Irregular Astigmatism (TCIA in Diopter)
5 minutes
Predicted spherical equivalent (SE) calculated with Barrett Universal II formula before and after 5 minutes of installation of artificial tears (sodium hyaluronate 0.1% or 0.3% eye drops).
Time Frame: 5 minutes
Predicted spherical equivalent (SEQ in Diopter)
5 minutes
Postoperative spherical equivalent (SE) measured one month after surgery.
Time Frame: one month after surgery
Postoperative spherical equivalent (SE in Diopters)
one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Ling Bai, MD,PhD, Second Affiliated Hospital of Xi'an JiaoTong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ANTICIPATED)

February 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

January 10, 2021

First Posted (ACTUAL)

January 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 10, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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