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

Dry Eye Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706455
• Other study ID #: 20210312
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 2021

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Ling Bai, MD,PhD
• Phone: 13571495415
• Email: larkling[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• sodium hyaluronate 0.1%
Instillation of one drop sodium hyaluronate 0.1%
• sodium hyaluronate 0.3%
Instillation of one drop sodium hyaluronate 0.3%

Locations

Country	Name	City	State
China	Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Postoperative spherical equivalent (SE) measured one month after surgery.	Postoperative spherical equivalent (SE in Diopters)	one month after surgery