NCT04172857

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

3.7 years

First QC Date

November 19, 2019

Last Update Submit

November 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relapse of MG

    MG relapse after the anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).

    follow up: 3 to 31 months

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Iridectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher;clinical research center

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

May 1, 2015

Primary Completion

January 20, 2019

Study Completion

January 30, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11