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

NCT ID: NCT05201677

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-06-01

Brief Summary

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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) .

Detailed Description

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Conditions

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High Myopia Low Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High myopia with axial length between 26 mm and 28 mm

The patients' axial length is between 26 mm and 28 mm

Group Type EXPERIMENTAL

Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision

Intervention Type PROCEDURE

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.

High myopia with axial length more than 28 mm

The patients' axial length is more than 28 mm

Group Type EXPERIMENTAL

Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yune Zhao

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dandan Wang

Role: CONTACT

18258227706

Facility Contacts

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Dandan Wang, MD

Role: primary

18258227706

References

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Wang D, Shi J, Guan W, Zhu M, Lou X, Zhao Y, Chang P, Zhao Y. Fluid Supplementation Through Weakened Zonules via Side-Port Incision to Maintain Intraocular Pressure in High Myopic Eyes. Ophthalmol Ther. 2023 Dec;12(6):3323-3336. doi: 10.1007/s40123-023-00814-w. Epub 2023 Oct 9.

Reference Type DERIVED
PMID: 37812307 (View on PubMed)

Other Identifiers

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WDD-High myopia-Low IOP

Identifier Type: -

Identifier Source: org_study_id

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