CataractNCT05834465
High Intraocular Pressure After Cataract Surgery
An observational study of Cataract and Intraocular Pressure, run by Wenzhou Medical University at 1 site in China.
Trial summary
Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cataract, Intraocular Pressure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Oct 2023
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation" 2 hours after using a non-contact tonometer (FT-1000, TOMEY, JAPAN) to check that the intraocular pressure exceeds 28mmHg accompanied by corneal edema, anterior chamber radiation and age-related cataract patients over 60 years of age is required.
Who may be able to join
- Patients over 60 years old who underwent simple age-related cataract surgery in Eye Hospital of Wenzhou Medical University, the operation was successful, and there were no intraoperative complications such as posterior capsule rupture;
- Measurements were taken before and after drainage, and all data were complete ;
- The patient agrees and accepts the study.
Who cannot join
- Preoperative glaucoma, ocular hypertension, iritis, uveitis and other eye diseases, as well as other eye diseases and serious systemic diseases that may affect the prognosis of surgery, such as corneal lesions, vitreous volume blood, retinal detachment, poor blood sugar control in diabetes, etc.
- Previous history of eye trauma, etc.
- Cannot cooperate with the completion of intraocular pressure measurement and CASIA2 examination.
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
Pingjun Chang, 18868410303, 364669877@qq.com
About this study
Official title: Efficacy Evaluation of Anterior Chamber Drainage in Patients for High Intraocular Pressure After Cataract Surgery
Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure
Read the detailed description
To explore the effect of different degrees of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure
- Conditions
- Cataract, Intraocular Pressure
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | After using a non-contact tonometer to measure, the intraocular pressure is reduced by 0-10mmHg. | |
| Group 2 | After using a non-contact tonometer to measure, the intraocular pressure is reduced by 10-20mmHg. | |
| Group 3 | After using a non-contact tonometer to measure, the intraocular pressure is reduced over 20mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The position of IOL through tilt (tilt in degree)
Evaluation of the position of IOL through tilt (tilt in degree)
Measured: Two hours after cataract surgery (i.e. before anterior chamber drainage)
The position of IOL through decentration (decentration in millimeter)
Evaluation of the position of IOL through decentration (decentration in millimeter)
Measured: Two hours after cataract surgery (i.e. before anterior chamber drainage)
The position of IOL through tilt (tilt in degree)
Evaluation of the position of IOL through tilt (tilt in degree)
Measured: Immediately after anterior chamber drainage
The position of IOL through decentration (decentration in millimeter)
Evaluation of the position of IOL through decentration (decentration in millimeter)
Measured: Immediately after anterior chamber drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834465
- Sponsor's protocol ID
- 20230301CTR
- Status last verified
- Jun 2023
- First submitted
- 24 Mar 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Anterior Chamber Drainage in Patients for High Intraocular Pressure After Cataract Surgery
- ClinicalTrials.gov ID
- NCT05834465
- Acronym / sponsor ID
- 20230301CTR
- Conditions
- Cataract, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 28 Apr 2023 (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.
Effectiveness of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure
Detailed description
To explore the effect of different degrees of anterior chamber drainage on the structure of the anterior chamber, the position of the intraocular lens and the shape of the corneal incision in the early stage of cataract surgery with high intraocular pressure
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –After using a non-contact tonometer to measure, the intraocular pressure is reduced by 0-10mmHg. |
| Group 2 | – | –After using a non-contact tonometer to measure, the intraocular pressure is reduced by 10-20mmHg. |
| Group 3 | – | –After using a non-contact tonometer to measure, the intraocular pressure is reduced over 20mmHg. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation" 2 hours after using a non-contact tonometer (FT-1000, TOMEY, JAPAN) to check that the intraocular pressure exceeds 28mmHg accompanied by corneal edema, anterior chamber radiation and age-related cataract patients over 60 years of age is required.
Key inclusion criteria (3 listed)
- Patients over 60 years old who underwent simple age-related cataract surgery in Eye Hospital of Wenzhou Medical University, the operation was successful, and there were no intraoperative complications such as posterior capsule rupture;
- Measurements were taken before and after drainage, and all data were complete ;
- The patient agrees and accepts the study.
Key exclusion criteria (3 listed)
- Preoperative glaucoma, ocular hypertension, iritis, uveitis and other eye diseases, as well as other eye diseases and serious systemic diseases that may affect the prognosis of surgery, such as corneal lesions, vitreous volume blood, retinal detachment, poor blood sugar control in diabetes, etc.
- Previous history of eye trauma, etc.
- Cannot cooperate with the completion of intraocular pressure measurement and CASIA2 examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The position of IOL through tilt (tilt in degree)
Time frame: Two hours after cataract surgery (i.e. before anterior chamber drainage)
Evaluation of the position of IOL through tilt (tilt in degree)
The position of IOL through decentration (decentration in millimeter)
Time frame: Two hours after cataract surgery (i.e. before anterior chamber drainage)
Evaluation of the position of IOL through decentration (decentration in millimeter)
The position of IOL through tilt (tilt in degree)
Time frame: Immediately after anterior chamber drainage
Evaluation of the position of IOL through tilt (tilt in degree)
The position of IOL through decentration (decentration in millimeter)
Time frame: Immediately after anterior chamber drainage
Evaluation of the position of IOL through decentration (decentration in millimeter)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Cataract and Intraocular Pressure, run by Wenzhou Medical University 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 3 inclusion and 3 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 29 Jun 2023. 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 Pingjun Chang (18868410303, 364669877@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of IOL through tilt (tilt in degree) (time frame: Two hours after cataract surgery (i.e. before anterior chamber drainage)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.