NCT04706455

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 30 Years – 95 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	sodium hyaluronate 0.1%	Instillation of one drop sodium hyaluronate 0.1%
DEVICE	sodium hyaluronate 0.3%	Instillation of one drop sodium hyaluronate 0.3%

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-02-01
• Completion: 2021-03-01
• First posted: 2021-01-12
• Last updated: 2021-01-12

Locations

1 site across 1 country: China