Glaucoma SecondaryNCT04172857
Treatment of Malignant Glaucoma by Anterior Vitrectomy From Two Different Approaches
An observational study of Glaucoma Secondary, run by Wenzhou Medical University.
Trial summary
To compare the surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma Secondary
- What is being tested?
- anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 30 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The medical records of all patients who developed clinical evidence of MG after Phaco-IOL-GSL, at the Affiliated Eye Hospital of Wenzhou Medical University from May 2015 to February 2018, were reviewed.
Who may be able to join
- MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP).
Who cannot join
- The diagnosis was made only after confirming the absence of choroidal detachment or hemorrhage and posterior segment mass lesion, using B-scan ultrasonography or ophthalmoscopy
About this study
Official title: Treatment of Malignant Glaucoma Secondary to Cataract Surgery Combined With Goniosynechialysis by Anterior Vitrectomy From Two Different Approaches
To compare the surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).
- Conditions
- Glaucoma Secondary
- Being tested
- anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomyProcedure or surgery
First, a 23-G incision was made at the peripheral inferior temporal sector of the cornea and connected with an anterior chamber infusion cannula. Another corneal incision was made at the superior temporal sector or superior nasal sector, and Viscoat® (Bausch \& Lomb, Shandong, China) was infused though the incision to fill the anterior chamber. Iridotomy was performed through the incision using Wescott scissors and toothed forceps. Hyaloidectomy and zonulectomy were performed through a peripheral iris defect using an anterior chamber approach to set up a pathway between the anterior chamber and the vitreous cavity. We repeatedly carried out vitrectomy around the pathway to reduce the risk of postoperative re-obstruction of the tunnel created.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of MG
MG relapse after the anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).
Measured: follow up: 3 to 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 May 2015
- Primary completion20 Jan 2019
- Study completion30 Jan 2019
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 Glaucoma SecondaryStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172857
- Sponsor's protocol ID
- QZB-MG
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Qian Z, Chan YK, Wei L, Zheng B, Nie L, Pan W. Evaluation of Two Different Anterior Vitrectomies for Fluid Misdirection Syndrome Secondary to Cataract Surgery Combined with Goniosynechialysis. J Ophthalmol. 2020 Mar 23;2020:1934086. doi: 10.1155/2020/1934086. eCollection 2020.
PubMed 32280517
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Malignant Glaucoma Secondary to Cataract Surgery Combined With Goniosynechialysis by Anterior Vitrectomy From Two Different Approaches
- ClinicalTrials.gov ID
- NCT04172857
- Acronym / sponsor ID
- QZB-MG
- Conditions
- Glaucoma Secondary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 21 Nov 2019 (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 surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The medical records of all patients who developed clinical evidence of MG after Phaco-IOL-GSL, at the Affiliated Eye Hospital of Wenzhou Medical University from May 2015 to February 2018, were reviewed.
Key inclusion criteria (1 listed)
- MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP).
Key exclusion criteria (1 listed)
- The diagnosis was made only after confirming the absence of choroidal detachment or hemorrhage and posterior segment mass lesion, using B-scan ultrasonography or ophthalmoscopy
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 |
|---|---|---|
| anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomyFirst, a 23-G incision was made at the peripheral inferior temporal sector of the cornea and connected with an anterior chamber infusion cannula. Another corneal incision was made at the superior temporal sector or superior nasal sector, and Viscoat® (Bausch \& Lomb, Shandong, China) was infused though the incision to fill the anterior chamber. Iridotomy was performed through the incision using Wescott scissors and toothed forceps. Hyaloidectomy and zonulectomy were performed through a peripheral iris defect using an anterior chamber approach to set up a pathway between the anterior chamber and the vitreous cavity. We repeatedly carried out vitrectomy around the pathway to reduce the risk of postoperative re-obstruction of the tunnel created. | Procedure or surgery | – |
Primary outcome
Relapse of MG
Time frame: follow up: 3 to 31 months
MG relapse after the anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Derived from this study: PubMed 32280517Qian Z, Chan YK, Wei L, Zheng B, Nie L, Pan W. Evaluation of Two Different Anterior Vitrectomies for Fluid Misdirection Syndrome Secondary to Cataract Surgery Combined with Goniosynechialysis. J Ophthalmol. 2020 Mar 23;2020:1934086. doi: 10.1155/2020/1934086. eCollection 2020.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Glaucoma Secondary
RecruitingPhase 2
Phase 2 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Glaucoma
Not yet recruiting
Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries
Open Angle Glaucoma (OAG), Primary Open Angle Glaucoma (POAG)
RecruitingPhase 3
Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Glaucoma
Not yet recruiting
Prospective Electronic Polygenic Risk Study - Second Phase
Coronary Artery Disease, Glaucoma
Active, not recruitingObservational study
Glaucoma Following Pediatric Cataract Surgery
Glaucoma Following Pediatric Cataract Surgery, Glaucoma Secondary
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Secondary, run by Wenzhou Medical University.
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: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse of MG (time frame: follow up: 3 to 31 months). 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 NCT04172857, 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 Nov 2019.