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NCT04297930

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

Completed Last updated 27 March 2020
What this trial tests

trial testing Paul Glaucoma Implant Surgery in Glaucoma in 82 participants. Completed in 1 December 2019.

Timeline
1 December 2017
Primary endpoint
1 December 2019
1 December 2019

Quick facts

Lead sponsorNational University Hospital, Singapore
StatusCompleted
Study typeOBSERVATIONAL
Enrollment82
Start date1 December 2017
Primary completion1 December 2019
Estimated completion1 December 2019
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

National University Hospital, Singapore

Who can join

Adults 21 to 80, any sex, with Glaucoma or Glaucoma, Open-Angle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Two-Year Outcomes of the Paul Glaucoma Implant for Treatment of Glaucoma.
    Tan MCJ, Choy HYC, Koh Teck Chang V, Aquino MC, et al · · 2022 · cited 34× · PMID 35180153 · DOI 10.1097/ijg.0000000000001998
  2. Three-Year Outcomes of the Paul Glaucoma Implant for Treatment of Glaucoma.
    Tan MCJ, Ong CW, Aquino MC, Lun KW, et al · · 2024 · cited 21× · PMID 38506749 · DOI 10.1097/ijg.0000000000002369

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Other recruiting trials for Glaucoma

Currently open trials in the same condition.

Other National University Hospital, Singapore trials

Trials by the same sponsor.

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Data sources for this page

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