Condition category
Eye Diseases
Date applied
18/05/2010
Date assigned
17/06/2010
Last edited
17/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Ginger Clasby

ORCID ID

Contact details

Transcend Medical
20 Pacifica
Suite 220
Irvine
92618
United States of America
gclasby@transcendmedical.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TMI-08-01C

Study information

Scientific title

A pilot study to assess the safety and efficacy of the Transcend CyPass glaucoma implant in combination with cataract surgery in patients with open angle glaucoma

Acronym

Study hypothesis

The objectives of the study are to evaluate the safety and effectiveness of the Transcend CyPass implant in combination with cataract surgery in patients with primary open-angle glaucoma (POAG).

Ethics approval

No ethics approval required as this was a prospective registry study with no interventions.

Study design

Open-label controlled prospective pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Primary open angle glaucoma, ocular hypertension

Intervention

Group 1: eyes will undergo both cataract surgery and CyPass implantation and patients will be followed for 12 months following surgery.
Group 2: eyes will undergo only cataract surgery and patients will be followed for 12 months following surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at 12 months:
1. Best corrected visual acuity
2. Intraocular pressure (IOP)
3. Manifest refraction
4. Biomicropscopy
5. Gonioscopy
6. Ophthalmoscopy (dilated)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/04/2008

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients must be age 18 or over, either sex
2. Patients must have diagnosis of primary open angle glaucoma or ocular hypertension (OHT). Also acceptable are patients diagnosed with open angle glaucoma associated with pseudoexfoliation syndrome or pigmentary glaucoma.
3. Candidacy for cataract surgery in the study eye as determined by the clinical judgment of the investigator
4. Patients who have had previous trabeculoplasty glaucoma procedures such as argon laser trabeculoplasty (ALT) or selective laser trabeculoplasty (SLT)
5. Patients must have intraocular pressure (IOP) of greater than or equal to 21 mmHg and less than or equal to 40 mmHg while on maximal tolerated medical therapy, documented at two sequential visits at any time of day, at least 48 hours apart, within 30 days prior to surgery
6. Patients must have sufficient space in the angle to accommodate the device
7. Patients must be able to understand the requirements of the study and be willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 patients

Participant exclusion criteria

1. Patients with previous glaucoma surgery, including trabeculectomy or implantation of any aqueous shunt device, or the following glaucoma surgeries: viscocanulostomy, cyclophotocoagulation, or collagen implant
2. Patients with any ophthalmic surgery within 3 months in the eye to be treated
3. Patients with diagnosis of angle closure following penetrating keratoplasty, neovascular glaucoma, congenital glaucoma, developmental glaucoma or previous goniotomy
4. Patients with active uveitis within six months or other secondary glaucomas (other than pseudoexfoliation syndrome or pigmentary glaucoma)
5. Patients with best corrected visual acuity less than 20/200 in the fellow eye
6. Patients with clinically significant inflammation or infection within 6 months prior to the study
7. Patients with active diabetic retinopathy
8. Patients who have any uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the investigator
9. Intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device
10. A medical condition, serious illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
11. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
12. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device
13. Patients who are pregnant or planning to be pregnant during the course of the study

Recruitment start date

30/04/2008

Recruitment end date

30/04/2009

Locations

Countries of recruitment

Malaysia, Mexico, Philippines

Trial participating centre

Transcend Medical
Irvine
92618
United States of America

Sponsor information

Organisation

Transcend Medical, Inc.™ (USA)

Sponsor details

c/o Ginger Clasby
20 Pacifica
Suite 220
Irvine
92618
United States of America
gclasby@transcendmedical.com

Sponsor type

Industry

Website

http://www.transcendmedical.com/index.htm

Funders

Funder type

Industry

Funder name

Transcend Medical, Inc.™ (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes