Comparison Between Deep Sclerectomy and Traditional Trabe... | NCT01460017

Studies
Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma

NCT01460017

Sponsor

King Saud University

Status

Unknown status

Last Update Posted

Oct 26, 2011Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Congenital Glaucoma

Interventions

Deep Sclerectomy
Combined Trab

Countries

Saudi Arabia

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Oct 25, 2011

First Submission Date that Met QC Criteria

Oct 25, 2011

First Posted Date

Oct 26, 2011Estimated

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

Oct 25, 2011

Last Update Posted Date

Oct 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.

Detailed Description

Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DS arm	Active Comparator	Deep sclerectomy surgery will be conduct in this arm	Procedure: Deep Sclerectomy
Trab arm	Active Comparator	combined Trabeculectomy and Trabeculotomy surgery will be conducted in this arm	Procedure: Combined Trab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep Sclerectomy	Procedure	Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in IOP	decrease in the intraocular pressure to the normal limit (<22 - >6) mmHg	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
Within the age of (0 - 12).

Exclusion Criteria:

Cases of congenital glaucoma with previous intervention.
Age above 12 Yrs.
Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saleh A. Al-Obeidan, MD	King Saud University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Abdul Aziz University Hospital		Riyadh	Riyadh Region	11411	Saudi Arabia

Type	Date	Date Unknown
Release	Apr 21, 2013
Reset	Jun 4, 2013

Submission Tracking

Estimated Results First Submitted Date

Apr 21, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 21, 2013			Jun 4, 2013

Condition Browse Module

MeSH Terms

ID	Term
D006871	Hydrophthalmos

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided