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

• Sponsor: Yune Zhao (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05201677
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

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) .

Condition or Disease	Intervention/Treatment	Phase
High Myopia; Low Intraocular Pressure	Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure [two minutes]

   Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang	China	325027

Sponsors and Collaborators

• Yune Zhao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT05201677
• Other Study ID Numbers: WDD-High myopia-Low IOP
• First Posted: Jan 21, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Myopia; Ocular Hypotension

Study Results

No Results Posted as of Jan 21, 2022