The Incidence and Risk Factors of Glaucoma After Congenital Cataract SurgeryNCT04521907
Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery
An observational study of The Incidence and Risk Factors of Glaucoma After Congenital Cataract Surgery, run by Wenzhou Medical University at 1 site in China.
Trial summary
A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- The Incidence and Risk Factors of Glaucoma After Congenital Cataract Surgery
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2011to 1 Oct 2020
- 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 1 month to 14 years
- All sexes
- Child
Study population: Patients who underwent congenital cataract surgery at Eye hospital of Wenzhou Medical University
Who may be able to join
- Patients who underwent lensectomy combined with limited anterior vitrectomy, with or without IOL implantation for congenital cataract, all by one surgeon
Who cannot join
- Patient had a preoperative IOP above 21mmHg, glaucoma, coexistent uveitis, metabolic syndromes/diseases or exposure to radiation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027
zhao yun-e, +86 13819707056
About this study
A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. We recorded patient demographics and incidence and risk factors for glaucoma-related adverse event. This study to identify the incidence of and risk factors associated with postoperative glaucoma at various durations after congenital cataract surgery.
- Keywords
- Glaucoma, Incidence, Congenital cataract surgery
- Medical subject headings
- Glaucoma
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 | Group 1 includes patients who underwent cataract surgery with primary IOL implantation | |
| Group 2 | Group 2 includes patients who underwent cataract surgery with secondly IOL implantation | |
| Group 3 | Group 3 includes patients who underwent cataract surgery without IOL implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of glaucoma after congenital cataract surgery
The incidence of glaucoma at various durations after congenital cataract surgery
Measured: 2020.6.30
Demographic data, including sex, age at surgery, gestational history, family history of cataract, and laterality of disease, were collected.
Risk factors
Measured: 2020.6.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 May 2011
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Incidence and Risk Factors of Glaucoma After Congenital Cataract SurgeryStudies 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
- Retrospective
- Enrolment
- 177 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
- NCT04521907
- Sponsor's protocol ID
- GRAE2 -zzh
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 21 Aug 2020
- 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 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlative Study on Incidence and Risk Factors of Glaucoma-related Adverse Event at Various Durations After Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT04521907
- Acronym / sponsor ID
- GRAE2 -zzh
- Keywords
- Glaucoma, Incidence, Congenital cataract surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2011 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 21 Aug 2020 (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.
A retrospective chart review of 264 eyes from 177 patients was performed who underwent congenital cataract surgery before the age of 14 years. All patients' surgery was performed by the same experienced surgeon at the Eye Hospital of Wenzhou Medical University from May 2011 to March 2019. We recorded patient demographics and incidence and risk factors for glaucoma-related adverse event. This study to identify the incidence of and risk factors associated with postoperative glaucoma at various durations after congenital cataract surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1 includes patients who underwent cataract surgery with primary IOL implantation |
| Group 2 | – | –Group 2 includes patients who underwent cataract surgery with secondly IOL implantation |
| Group 3 | – | –Group 3 includes patients who underwent cataract surgery without IOL implantation. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients who underwent congenital cataract surgery at Eye hospital of Wenzhou Medical University
Key inclusion criteria (1 listed)
- Patients who underwent lensectomy combined with limited anterior vitrectomy, with or without IOL implantation for congenital cataract, all by one surgeon
Key exclusion criteria (1 listed)
- Patient had a preoperative IOP above 21mmHg, glaucoma, coexistent uveitis, metabolic syndromes/diseases or exposure to radiation.
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
Incidence of glaucoma after congenital cataract surgery
Time frame: 2020.6.30
The incidence of glaucoma at various durations after congenital cataract surgery
Demographic data, including sex, age at surgery, gestational history, family history of cataract, and laterality of disease, were collected.
Time frame: 2020.6.30
Risk factors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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 The Incidence and Risk Factors of Glaucoma After Congenital Cataract Surgery, 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 1 inclusion and 1 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 Aug 2020. 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 Zuhui zhang (+86 15268840754, zhzhangeye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of glaucoma after congenital cataract surgery (time frame: 2020.6.30). 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 21 Aug 2020.