Modified Trabeculectomy for Glaucoma Surgery

NCT ID: NCT04019210

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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IOP Decreased

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MODIFIED TRABECULECTOMY

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.

Group Type EXPERIMENTAL

MODIFIED TRABECULECTOMY

Intervention Type PROCEDURE

Rectangular scleral flap

Interventions

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MODIFIED TRABECULECTOMY

Rectangular scleral flap

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1ery glacouma

Exclusion Criteria

* Previous surgery
Minimum Eligible Age

30 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hassan Lotfy Fahmy

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut U

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hassan 58 Lotfy, Professor

Role: CONTACT

01020833002 ext. 20

Facility Contacts

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Hasan 58 Lotfy, Professor

Role: primary

01020833002 ext. 20

Other Identifiers

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2323298

Identifier Type: -

Identifier Source: org_study_id

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