High MyopiaNCT05201677
Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
A study testing Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision in people with High Myopia and Low Intraocular Pressure, run by Yune Zhao at 1 site in China.
Trial 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) . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Myopia, Low Intraocular Pressure
- What is being tested?
- Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
- Surgery without complications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
Dandan Wang, MD, 18258227706, wangdan4827716@yahoo.com.cn
About this study
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) .
- Conditions
- High Myopia, Low Intraocular Pressure
- Being tested
- Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision
- Medical subject headings
- Ocular Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High myopia with axial length between 26 mm and 28 mm | Experimental | The patients' axial length is between 26 mm and 28 mm Receives: Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision |
| High myopia with axial length more than 28 mm | Experimental | The patients' axial length is more than 28 mm Receives: Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer
Measured: two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Nov 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201677
- Sponsor's protocol ID
- WDD-High myopia-Low IOP
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37812307
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Operation of Low Intraocular Pressure in Phacoemulsification for Patients With High Myopia Complicated With Cataract
- ClinicalTrials.gov ID
- NCT05201677
- Acronym / sponsor ID
- WDD-High myopia-Low IOP
- Conditions
- High Myopia, Low Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High myopia with axial length between 26 mm and 28 mm | Experimental | Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incisionThe patients' axial length is between 26 mm and 28 mm |
| High myopia with axial length more than 28 mm | Experimental | Procedure: Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incisionThe patients' axial length is more than 28 mm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patients with high myopia and cataract who plan to receive cataract surgery in our hospital
- Surgery without complications
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incisionAfter 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. | Procedure or surgery | High myopia with axial length between 26 mm and 28 mm, High myopia with axial length more than 28 mm |
Primary outcome
Intraocular pressure
Time frame: two minutes
Measurement of intraocular pressure during cataract surgery by iCare rebound tonometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 37812307Wang 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.
- Individual participant dataSharing planned: Undecided
Related trials for High Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Active, not recruiting
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
Refractive Errors
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement of perfusion fluid through the subiris suspensory ligament space from the lateral incision in people with High Myopia and Low Intraocular Pressure, run by Yune Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dandan Wang (18258227706, wangdan4827716@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: two minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05201677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.