Clinical trial NCT04706455: Effect of Artificial Tears on the Parameters of the Eye and Its Impact on IOL Power Calculation for Cataract Surgery
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract Senile
Dry Eye
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: DIAGNOSTIC

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)

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

Primary outcomes:
measure: 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).
timeFrame: 5 minutes
measure: 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).
timeFrame: 5 minutes
measure: 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).
timeFrame: 5 minutes
measure: 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).
timeFrame: 5 minutes
measure: 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).
timeFrame: 5 minutes
measure: 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).
timeFrame: 5 minutes
measure: 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).
timeFrame: 5 minutes
measure: Postoperative spherical equivalent (SE) measured one month after surgery.
timeFrame: one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Ling Bai, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: