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

NCT ID: NCT04706455

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-03-31

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)

Conditions

Cataract Senile; Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

sodium hyaluronate 0.1%

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.

Group Type: ACTIVE_COMPARATOR

sodium hyaluronate 0.1%

Intervention Type: DEVICE

Instillation of one drop sodium hyaluronate 0.1%

sodium hyaluronate 0.3%

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.

Group Type: ACTIVE_COMPARATOR

sodium hyaluronate 0.3%

Intervention Type: DEVICE

Instillation of one drop sodium hyaluronate 0.3%

Interventions

sodium hyaluronate 0.1%

Instillation of one drop sodium hyaluronate 0.1%

Intervention Type: DEVICE

sodium hyaluronate 0.3%

Instillation of one drop sodium hyaluronate 0.3%

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Bai, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Xi'an Jiaotong University

Locations

Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ling Bai, MD,PhD

Role: CONTACT

larkling@163.com

13571495415

Facility Contacts

Ling Bai, MD,PhD

Role: primary

larkling@163.com

13571495415

Other Identifiers

20210312

Identifier Type: -

Identifier Source: org_study_id