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Aqueous Dynamics and Glaucoma Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02839590
Recruitment Status : Unknown
Verified July 2016 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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).

Condition or disease Intervention/treatment
Glaucoma Ocular Hypertension Device: HiFU Device: Baerveldt implant Device: Ahmed implant Device: STARflo Device: Hydrus Microstent implant Device: iStent implant Device: Kahook Dual Blade

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Glaucoma Surgery on Aqueous Dynamics in Patients With Glaucoma or Ocular Hypertension: An Observational Study
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
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
Ciliary Ablation Treatment ( HiFu ultrasound treatment)

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
External (sub-conjunctival) Drainage Surgery (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
External (sub-conjunctival) Drainage Surgery (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
Suprachoroidal Shunt Surgery (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
Trans-trabecular meshwork implants (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
Trans-trabecular meshwork implants (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
It removes part of the trabecular meshwork




Primary Outcome Measures :
  1. Change from baseline of Intraocular pressure at 12 months [ Time Frame: baseline and 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

  2. Change from baseline of aqueous flow at 12 months [ Time Frame: baseline and12 months ]
    This parameter is measured by fluorophotometry

  3. Change from baseline of uveoscleral outflow at 12 months [ Time Frame: baseline and 12 months ]
    It would be calculated by Goldmann's equation

  4. Change from baseline of trabecular outflow facility at 12 months [ Time Frame: baseline and 12 months ]
    It will be measured by Electronic Schiotz tonography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Any inclusion criteria not met

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839590


Contacts
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Contact: K Sheng Lim, MD +442071884885 shenglim@gmail.com
Contact: Stephanie Jones, BA 02071884885 stephanie.jones@gstt.nhs.uk

Locations
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United Kingdom
St Thomas Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: K Sheng Lim, MD    +442071884885    shenglim@gmail.com   
Contact: Stephanie Jones, BSc    +442071884885    stephanie.jones@gsst.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: K Sheng Lim, MD Guy's and St Thomas NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02839590    
Other Study ID Numbers: 163050
15/LO/1809 ( Other Identifier: Research Ethics Committee )
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data (IPD)
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Glaucoma
Ocular hypertension
Aqueous dynamics
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases