Glaucoma, Open-AngleNCT04920227
Comparation of CLASS Combined With Phacoemulsification and CLASS Alone in the Treatment of Primary Open Angle Glaucoma
A study testing phacoemulsification; in people with Glaucoma, Open-Angle, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To compare the effect of intraocular pressure control and the incidence of peripheral anterior synechia between CLASS combined with phacoemulsification and CLASS alone in the treatment of primary open-angle glaucoma Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- phacoemulsification;
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2020to Aug 2023
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary open-angle glaucoma patients with cataract in our Ophthalmic Center;
- Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control;
- The patients were aged from 50 to 80 years old, regardless of gender;
- Class operation and phacoemulsification were performed;
- Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
- Informed consent has been signed.
Who cannot join
- Allergic to any perioperative medication in this study;
- History of ocular trauma;
- Any previous intraocular surgery;
- Angle of the chamber was narrow by angle microscopy (Schaffer grade III and below);
- Patients diagnosed as secondary glaucoma;
- Optic atrophy caused by other reasons;
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- The serious complications such as posterior capsule rupture and choroidal hemorrhage occurred during the operation;
- Serious complications of eyes occurred after operation;
- The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
- Women in pregnancy, lactation or planned pregnancy;
- The researchers believe that the patient's condition may put the patient at significant risk, and may confuse the research results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang
Kaijun Wang, MD, +86 0571 87783759, wkj992@126.com
About this study
Official title: Comparation of CO2 Laser-Assisted Sclerectomy Surgery Combined With Phacoemulsification and CO2 Laser-Assisted Sclerectomy Surgery Alone in the Treatment of Primary Open Angle Glaucoma
To compare the effect of intraocular pressure control and the incidence of peripheral anterior synechia between CLASS combined with phacoemulsification and CLASS alone in the treatment of primary open-angle glaucoma
Read the detailed description
Group A: CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification; Group B: simple CO2 Laser-Assisted Sclerectomy Surgery. The patients were followed up for 1 year. The incidence of peripheral anterior synechia and Intraocular pressure changes at 1 day, 1 week, 1 month, 2 months, 3 months, 6 months and 12 months were observed and compared between the two groups.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- phacoemulsification;
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification;Procedure or surgery
Group A: class combined with phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| CLASS+PHACO | Experimental | CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification Receives: Procedure: phacoemulsification; |
| CLASS | No intervention | CO2 Laser-Assisted Sclerectomy Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peripheral anterior synechia
Incidence of peripheral anterior synechia
Measured: 1 year
Intraocular pressure
Intraocular pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start2 Sep 2020
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaijun Wang, MD, Study director, Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920227
- Sponsor's protocol ID
- 2020-528
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation of CO2 Laser-Assisted Sclerectomy Surgery Combined With Phacoemulsification and CO2 Laser-Assisted Sclerectomy Surgery Alone in the Treatment of Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT04920227
- Acronym / sponsor ID
- 2020-528
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 9 Jun 2021 (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.
To compare the effect of intraocular pressure control and the incidence of peripheral anterior synechia between CLASS combined with phacoemulsification and CLASS alone in the treatment of primary open-angle glaucoma
Detailed description
Group A: CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification; Group B: simple CO2 Laser-Assisted Sclerectomy Surgery. The patients were followed up for 1 year. The incidence of peripheral anterior synechia and Intraocular pressure changes at 1 day, 1 week, 1 month, 2 months, 3 months, 6 months and 12 months were observed and compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLASS+PHACO | Experimental | Procedure: phacoemulsification;CO2 Laser-Assisted Sclerectomy Surgery combined with phacoemulsification |
| CLASS | No intervention | –CO2 Laser-Assisted Sclerectomy Surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary open-angle glaucoma patients with cataract in our Ophthalmic Center;
- Topical use of hypotensive drugs in the treatment of poor or intolerable intraocular pressure control;
- The patients were aged from 50 to 80 years old, regardless of gender;
- Class operation and phacoemulsification were performed;
- Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
Key exclusion criteria (11 listed)
- Allergic to any perioperative medication in this study;
- History of ocular trauma;
- Any previous intraocular surgery;
- Angle of the chamber was narrow by angle microscopy (Schaffer grade III and below);
- Patients diagnosed as secondary glaucoma;
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 |
|---|---|---|
| phacoemulsification;Group A: class combined with phacoemulsification | Procedure or surgery | CLASS+PHACO |
Primary outcome
Incidence of peripheral anterior synechia
Time frame: 1 year
Incidence of peripheral anterior synechia
Intraocular pressure
Time frame: 1 year
Intraocular pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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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.
Kaijun Wang, MD study director
Eye Center, the 2nd Affiliated Hospital, Medical College of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification; in people with Glaucoma, Open-Angle, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 11 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 9 Jun 2021. 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 Kaijun Wang, MD (+86 0571 87783759, wkj992@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of peripheral anterior synechia (time frame: 1 year). The study lists 2 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 9 Jun 2021.