The Ghana Primary Tube Versus Trabeculectomy Study | NCT02088528

Studies
The Ghana Primary Tube Versus Trabeculectomy Study

NCT02088528

Sponsor

Tema Christian Eye Center

Status

Unknown status

Last Update Posted

Mar 17, 2014Estimated

Enrollment

298Estimated

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Aurolab glaucoma drainage device
Trabeculectomy with mitomycin-c

Countries

Ghana

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2021Estimated

Completion Date

Not provided

First Submitted Date

Mar 11, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2014

Last Update Posted Date

Mar 17, 2014Estimated

Name	Class
International Glaucoma Association	UNKNOWN
HCA International Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution.

The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

298Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aurolab glaucoma drainage device	Active Comparator		Device: Aurolab glaucoma drainage device
Trabeculectomy with mitomycin-c	Active Comparator		Procedure: Trabeculectomy with mitomycin-c

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aurolab glaucoma drainage device	Device	Patients undergoing surgery will receive an implant	Aurolab glaucoma drainage device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in intraocular pressure		3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

Secondary Outcomes

Measure	Description	Time Frame
Complication rates		1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years
Visual acuity		1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

Other Outcomes

Measure	Description	Time Frame
Patient satisfaction with communications by text message		1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 85 years, inclusive
Open angle glaucoma. Including primary open angle glaucoma, pseudoexfoliative and pigmentary glaucoma
Intraocular pressure 18 - 40 mmHg on maximal tolerated or maximal affordable medical therapy
Informed consent given and consent form signed.

Exclusion Criteria:

Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits
Pregnant or nursing women
No light perception vision
Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery
Previous ocular laser in study eye
Iris neovascularisation or proliferative retinopathy
Primary angle closure or primary angle closure glaucoma
Iridocorneal endothelial syndrome or anterior segment dysgenesis
Epithelial or fibrous downgrowth
Aphakia
Chronic or recurrent uveitis
Steroid-induced glaucoma
Severe posterior blepharitis
Unwilling to discontinue contact lens use after surgery
Previous cyclodestructive procedure
Glaucoma secondary to penetrating keratoplasty, trauma, retinal disease/surgery or neovascular disease
Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander Spratt, MBBCh FRCOphth	Contact	+233549446981		mail@gptvt.com

Overall Officials

Name	Affiliation	Role
Alexander Spratt, MBBCh FRCOphth	Tema Christian Eye Center	Principal Investigator
Keith Barton, MBBCh MD FRCP FRCOphth	Moorfields Eye Hospital NHS Foundation Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tema Christian Eye Center	Recruiting	Tema			Ghana

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D014130	Trabeculectomy
D016685	Mitomycin

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D008937	Mitomycins