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Status unknownNCT05201677Updated Jan 21, 2022

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

An interventional study of Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision in High Myopia and Low Intraocular Pressure, sponsored by Yune Zhao. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-01-21.

Sponsored by Yune Zhao · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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) .

02

Conditions studied

  • High Myopia
  • Low Intraocular Pressure

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSupplement 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.

05

What researchers measure

Primary outcomes

  1. Intraocular pressure

    Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer

    Time frame: two minutes

06

Study locations

1 of 1 sites recruiting
  • Eye Hospital of Wenzhou Medical College
    Wenzhou, Zhejiang 325027, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05201677
Lead sponsor
Yune Zhao
Responsible party
Yune Zhao (Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University) — Sponsor-investigator
First posted
Jan 21, 2022
Start date
Nov 1, 2021
Primary completion
Mar 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Jan 21, 2022

Study contacts

Dandan Wang
Contact
wangdan4827716@yahoo.com.cn
18258227706

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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