Modified Trabeculectomy for Glaucoma Surgery

IOP Decreased Clinical Trial

Official title:

Modified Trabeculectomy a New Procedure for Glaucoma Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04019210
• Other study ID #: 2323298
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2019

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Hassan 58 Lotfy, Professor
• Phone: 01020833002
• Email: hassaniron57[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A combination of hypotony, flat anterior chamber and choroidal detachment is the most common complications after filtering surgery. The purpose of this study is to present a new modification in standard trabeculectomy technique to reduce such complications.

Description:

Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane.

Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm. The horizontal distance between each point is 3.5 mm Figure(1). The application of the cautery continue till the color of the tissue becomes brown.

Then with aid of a 23-gauge needle we penetrate these cauterized points to create 4 holes, each of them is nearly 0.3-0.5 mm in length (the opening of each hole takes the shape of a slit). Through one of these holes iridectomy is done.

These holes drain the aqueous under the scleral flap with anatomical preservation of tissue in between.

Close the scleral flap by two 10-0 nylon suture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 62 Years

Eligibility

Inclusion Criteria:

• 1ery glacouma

Exclusion Criteria:

• Previous surgery

Related Conditions & MeSH terms

• Glaucoma
• IOP Decreased
• Ocular Hypotension

Intervention

Procedure:
• MODIFIED TRABECULECTOMY
Rectangular scleral flap

Locations

Country	Name	City	State
Egypt	Assiut U	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP	Decreased IOP with normal depth anterior chamber measured by Tonopen	6 month