Treatment Outcomes of a Novel Glaucoma Tube Shunt Implant for Intraocular Pressure Control in Eyes With Refractory Glaucoma

Surgery Clinical Trial

Official title:

Treatment Outcomes of a Novel Glaucoma Tube Shunt Implant for Intraocular Pressure Control in Eyes With Refractory Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297930
• Other study ID #: 2019/00136
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2020
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the effectiveness of lowering intraocular pressure and safety profile of the Paul Glaucoma Implant (Advanced Ophthalmic Innovations, Singapore). This is a non-comparative and single-arm observational study and all the participants were recruited between 1 Dec 2017 and 1 Dec 2018. Patients between age 21 - 80 years with glaucoma and an IOP deemed poorly controlled by the study team despite on maximal tolerated medical therapy were included in this study. The participants were recruited from 6 tertiary ophthalmology centers including National University Hospital, Singapore, Moorfields Eye Hospital, United Kingdom, St Thomas' Hospital, United Kingdom, Chulalongkorn University and Hospital, Thailand, International Specialist Eye Centre, Malaysia and Chinese University of Hong Kong, Hong Kong. All the eyes were followed-up for a period of 12 months after surgery. The examination and investigations included best corrected Snellen visual acuity, slit lamp examination, goldman applanation tonometry (GAT), dilated fundus examination and optic nerve head imaging. The participants are reviewed before surgery, 1 day, 1 week, 1 month, three months, 6 months and 12 months after surgery. All the data were captured in a standardized data-collection form for analysis. The primary outcome measure was failure, if was prospectively defined as IOP more than 21mmHg or less than a 20% reduction compared to pre-operative baseline on 2 consecutive visits after 3 months, IOP less than 6 mmHg on 2 consecutive visits after 3 months, reoperation for IOP-related indication, loss of light perception vision, or removal of the implant for any reason. Intraocular pressure outcomes, number of IOP-lowering medications and the rate of surgical complications were secondary outcome measures in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 21 - 80 years with glaucoma

• Poorly controlled intraocular pressure

Exclusion Criteria:

• Unable to give informed consent

• Age below 21 or above 80 years

• Without any suitable quadrants for tube shunt implant

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Intraocular Pressure
• Surgery

Intervention

Device:
• Paul Glaucoma Implant Surgery
This group of patients had glaucoma surgery with the Paul Glaucoma Implant

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	The primary outcome measure was surgical failure, if was prospectively defined as IOP more than 21mmHg or less than a 20% reduction compared to pre-operative baseline on 2 consecutive visits after 3 months, IOP less than 6 mmHg on 2 consecutive visits after 3 months, reoperation for IOP-related indication, loss of light perception vision, or removal of the implant for any reason	12 months
Secondary	Number of intraocular-pressure-lowering medications	Complete success was defined as IOP less than or equal to 21 mmHg and more than 5 mmHg, IOP reduced by more than or equal to 20% from baseline and medications were not used at either the 6 or 12 month visits; Qualified success is similarly defined but with the use of IOP-lowering medications. In addition, we also provided success rates based on alternative upper limit of IOP at 18 and 15 mmHg	12 months