search
Back to results

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

Primary Purpose

Cataract Senile, Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sodium hyaluronate 0.1%
sodium hyaluronate 0.3%
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cataract Senile

Eligibility Criteria

30 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sodium hyaluronate 0.1%

sodium hyaluronate 0.3%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
k-value (k, k1, k2 in Diopter)
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).
Axial length (AL in mm)
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).
Anterior chamber depth (ACD in mm)
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).
Sim K (k1, k2 in Diopter)
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).
Total Corneal Refractive Power (TCRP in Diopter),
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).
Total Corneal Irregular Astigmatism (TCIA in Diopter)
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).
Predicted spherical equivalent (SEQ in Diopter)
Postoperative spherical equivalent (SE) measured one month after surgery.
Postoperative spherical equivalent (SE in Diopters)

Secondary Outcome Measures

Full Information

First Posted
December 20, 2020
Last Updated
January 10, 2021
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
search

1. Study Identification

Unique Protocol Identification Number
NCT04706455
Brief Title
Effect of Artificial Tears on the Parameters of the Eye and Its Impact on IOL Power Calculation for Cataract Surgery
Acronym
IOL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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)
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile, Dry Eye

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Corneal topography and Biometry will be performed in individuals with age-relate cataract. 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. One of two artificial tear eye drops will be instilled in the eye, and corneal topography and biometry will be repeated after 5 minutes of application
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sodium hyaluronate 0.1%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sodium hyaluronate 0.3%
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
sodium hyaluronate 0.1%
Intervention Description
Instillation of one drop sodium hyaluronate 0.1%
Intervention Type
Device
Intervention Name(s)
sodium hyaluronate 0.3%
Intervention Description
Instillation of one drop sodium hyaluronate 0.3%
Primary Outcome Measure Information:
Title
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).
Description
k-value (k, k1, k2 in Diopter)
Time Frame
5 minutes
Title
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).
Description
Axial length (AL in mm)
Time Frame
5 minutes
Title
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).
Description
Anterior chamber depth (ACD in mm)
Time Frame
5 minutes
Title
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).
Description
Sim K (k1, k2 in Diopter)
Time Frame
5 minutes
Title
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).
Description
Total Corneal Refractive Power (TCRP in Diopter),
Time Frame
5 minutes
Title
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).
Description
Total Corneal Irregular Astigmatism (TCIA in Diopter)
Time Frame
5 minutes
Title
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).
Description
Predicted spherical equivalent (SEQ in Diopter)
Time Frame
5 minutes
Title
Postoperative spherical equivalent (SE) measured one month after surgery.
Description
Postoperative spherical equivalent (SE in Diopters)
Time Frame
one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Bai, MD,PhD
Phone
13571495415
Email
larkling@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Bai, MD,PhD
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Bai, MD,PhD
Phone
13571495415
Email
larkling@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs