NCT04706455

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

December 20, 2020

Last Update Submit

January 10, 2021

Conditions

Cataract SenileDry Eye

Outcome Measures

Primary Outcomes (8)

  • 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)

    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).

    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).

    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).

    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).

    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).

    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).

    Predicted spherical equivalent (SEQ in Diopter)

    5 minutes

  • Postoperative spherical equivalent (SE) measured one month after surgery.

    Postoperative spherical equivalent (SE in Diopters)

    one month after surgery

Study Arms (2)

sodium hyaluronate 0.1%

ACTIVE COMPARATOR

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%

sodium hyaluronate 0.3%

ACTIVE COMPARATOR

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%

Interventions

sodium hyaluronate 0.1%DEVICE

Instillation of one drop sodium hyaluronate 0.1%

sodium hyaluronate 0.1%
sodium hyaluronate 0.3%DEVICE

Instillation of one drop sodium hyaluronate 0.3%

sodium hyaluronate 0.3%

Eligibility Criteria

Age30 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ling Bai, MD,PhD

    Second Affiliated Hospital of Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Bai, MD,PhD

CONTACT

13571495415larkling@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

January 12, 2021

Study Start

December 1, 2020

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

CN(1)