Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract

Approximately 60 participants at Eye Hospital of Wenzhou Medical University during October,2021 to January 2022 will be enroll in the investigators' study. And dived them randomly into 2 groups:High myopia with axial length between 26 mm and 28 mm and High myopia with axial length more than 28 mm (30 eyes) .

Study Overview

• Status: Recruiting
• Conditions: High Myopia; Low Intraocular Pressure
• Intervention / Treatment: Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dandan Wang; Phone Number: 18258227706; Email: wangdan4827716@yahoo.com.cn

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • Eye Hospital of Wenzhou Medical College
      • Contact: Dandan Wang, MD; Phone Number: 18258227706; Email: wangdan4827716@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
• Surgery without complications

Exclusion Criteria:

• Patients who had other ocular diseases or had undergone internal eye surgery
• Patients with a history of myopic laser surgery
• Previous history of eye trauma
• Previous use of medications/eye drops that may alter IOP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High myopia with axial length between 26 mm and 28 mm; The patients' axial length is between 26 mm and 28 mm	Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision; After the capsule is filled with viscoelastic material, if the IOP is less than 10 mmHg, the investigators will supply the perfusion fluid through the subiris suspensory ligament space from the lateral incision.
Experimental: High myopia with axial length more than 28 mm; The patients' axial length is more than 28 mm	Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision; After the capsule is filled with viscoelastic material, if the IOP is less than 10 mmHg, the investigators will supply the perfusion fluid through the subiris suspensory ligament space from the lateral incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer	two minutes

Collaborators and Investigators

• Sponsor: Yune Zhao

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Myopia; Ocular Hypotension
• Other Study ID Numbers: WDD-High myopia-Low IOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No