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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04706455
Acronym
IOL
Enrollment
60
Registered
2021-01-12
Start date
2020-12-01
Completion date
2021-03-31
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile, Dry Eye

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)

Interventions

Instillation of one drop sodium hyaluronate 0.1%

DEVICEsodium hyaluronate 0.3%

Instillation of one drop sodium hyaluronate 0.3%

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
30 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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).5 minutesk-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).5 minutesAxial 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).5 minutesAnterior 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).5 minutesSim 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).5 minutesTotal 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).5 minutesTotal 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).5 minutesPredicted spherical equivalent (SEQ in Diopter)
Postoperative spherical equivalent (SE) measured one month after surgery.one month after surgeryPostoperative spherical equivalent (SE in Diopters)

Countries

China

Contacts

Primary ContactLing Bai, MD,PhD
larkling@163.com13571495415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026