NCT02839590

Brief Summary

There are currently many surgical options for patients with glaucoma and ocular hypertension (OHT), including the Hydrus Microstent implant, HiFU (High intensity Focused ultrasound), STAR flo, Kahook Dual Blade, Diode laser, trabeculectomy and the Baerveldt implant, but little is known about how these different surgical techniques used to treat glaucoma affect the flow of fluid through and out of the eye (aqueous dynamics).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

June 28, 2016

Last Update Submit

July 18, 2016

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaOcular hypertensionAqueous dynamics

Outcome Measures

Primary Outcomes (4)

  • Change from baseline of Intraocular pressure at 12 months

    It would be measured by Goldmann tonometer, iCare and pneumatonometer. The unit of measurement for all of these devices is the same. It is mmHg

    baseline and 12 months

  • Change from baseline of aqueous flow at 12 months

    This parameter is measured by fluorophotometry

    baseline and12 months

  • Change from baseline of uveoscleral outflow at 12 months

    It would be calculated by Goldmann's equation

    baseline and 12 months

  • Change from baseline of trabecular outflow facility at 12 months

    It will be measured by Electronic Schiotz tonography

    baseline and 12 months

Study Arms (7)

HiFu (ultrasound)

Manufacturer Name Eyehope Principle intended use Surgical treatment of uncontrolled glaucoma and OHT The device is currently routinely used in the department for the treatment of uncontrolled glaucoma and OHT, and will be used in accordance with usual clinical practice. It is not anticipated that there will be any changes to the device or its usage during the course of the study.

Device: HiFU

Baerveldt implant

Manufacturer Name Abbott Medical Optics Inc., Abbott Laboratories Inc., Abbott Park, Illinois, USA. Principle intended use Surgical treatment of uncontrolled glaucoma and OHT The device is currently routinely used in the department for the treatment of uncontrolled glaucoma and OHT, and will be used in accordance with usual clinical practice. It is not anticipated that there will be any changes to the device or its usage during the course of the study.

Device: Baerveldt implant

Ahmed Implant

Manufacturer Name New World Medical, Inc., 10763 Edison Court, Rancho Cucamonga, CA 91730, USA. Principle intended use Surgical treatment of uncontrolled glaucoma and OHT The device is currently routinely used in the department for the treatment of uncontrolled glaucoma and OHT, and will be used in accordance with usual clinical practice. It is not anticipated that there will be any changes to the device or its usage during the course of the study.

Device: Ahmed implant

STARflo

Manufacturer Name iSTAR Medical SA, Parc Créalys, Rue Phocas Lejeune, Bâtiment Regain 25/3, 5032 Isnes, Belgium. Principle intended use Surgical treatment of uncontrolled glaucoma and OHT The device is currently routinely used in the department for the treatment of uncontrolled glaucoma and OHT, and will be used in accordance with usual clinical practice. It is not anticipated that there will be any changes to the device or its usage during the course of the study.

Device: STARflo

Hydrus Microstent implant

Manufacturer Name Ivantis, Inc., 38 Discovery, Suite 150, Irvine, CA 92618, USA. Principle intended use Surgical treatment of uncontrolled glaucoma and OHT The device is currently routinely used in the department for the treatment of uncontrolled glaucoma and OHT, and will be used in accordance with usual clinical practice. It is not anticipated that there will be any changes to the device or its usage during the course of the study.

Device: Hydrus Microstent implant

iStent implant

Manufacturer Name Glaukos Corporation, 26051 Merit Circle, Suite 103, Laguna Hills, CA 92653, USA. Principle intended use Surgical treatment of uncontrolled glaucoma and OHT The device is currently routinely used in the department for the treatment of uncontrolled glaucoma and OHT, and will be used in accordance with usual clinical practice. It is not anticipated that there will be any changes to the device or its usage during the course of the study.

Device: iStent implant

Kahook Dual Blade

Manufacturer: New World Medical. Inc. Single use, ophthalmic blade Utilizes ab interno approach through a clear cornea micro incision Dual blades positioned for precise parallel incisions of the trabecular meshwork with minimal residual leaflets Maintains natural physiologic outflow pathways

Device: Kahook Dual Blade

Interventions

HiFUDEVICE

Ciliary Ablation Treatment ( HiFu ultrasound treatment)

HiFu (ultrasound)
Baerveldt implantDEVICE

External (sub-conjunctival) Drainage Surgery (Baerveldt implant)

Baerveldt implant
Ahmed implantDEVICE

External (sub-conjunctival) Drainage Surgery (Ahmed Implant)

Ahmed Implant
STARfloDEVICE

Suprachoroidal Shunt Surgery (STARflo)

STARflo
Hydrus Microstent implantDEVICE

Trans-trabecular meshwork implants (Hydrus Microstent implant).

Hydrus Microstent implant
iStent implantDEVICE

Trans-trabecular meshwork implants (iStent implant).

iStent implant
Kahook Dual BladeDEVICE

It removes part of the trabecular meshwork

Kahook Dual Blade

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One hundred patients with glaucoma or OHT and where a clinical decision has been made that they need glaucoma surgery will be included in the study such that 100 eyes undergoing surgery will be included together with the contralateral untreated eyes that will be used as controls for comparison with the treated eyes

You may qualify if:

  • Males or females between the ages of 18 and 90 (inclusive).
  • Able to understand the study and give informed consent.
  • Willing, able and available to participate in all aspects of the study.
  • Diagnosis of glaucoma or OHT which requires glaucoma surgery. (Defined as primary or secondary glaucoma; all types of secondary glaucoma may be included. Glaucoma will be diagnosed based on abnormal visual field testing and corresponding disc changes once seen by a glaucoma specialist.)
  • Able to undergo accurate fluorophotometry and tonography.

You may not qualify if:

  • Mental impairment conflicting with informed consent or follow-up.
  • Allergy to fluorescein.
  • Current use of any investigational drug or device or current participation in an interventional clinical trial.
  • Patients who might not adequately understand written information given in English or verbal explanations in English will not be included as participants in the study must be able to understand English to complete some of the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Thomas Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (1)

  • Ho H, Daas A, Ho J, Alaghband P, Galvis EA, de Antonio Ramirez A, Grassi P, Lim R, Lim KS. Intraocular pressure changes following topical ocular hypotensive medications washout. Br J Ophthalmol. 2021 Feb;105(2):205-209. doi: 10.1136/bjophthalmol-2019-315778. Epub 2020 Apr 10.

    PMID: 32277009DERIVED

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Glaucoma Drainage Implants

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • K Sheng Lim, MD

    Guy's and St Thomas NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

K Sheng Lim, MD

CONTACT

+442071884885shenglim@gmail.com

Stephanie Jones, BA

CONTACT

02071884885stephanie.jones@gstt.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 21, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD)

Locations

GB(1)