Status:

COMPLETED

Evaluation of Retina in Patients With Glaucoma Using Topical Prostaglandins Undergoing Trabeculectomy Surgery

Lead Sponsor:

Universidade Federal de Goias

Conditions:

Glaucoma

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The aim of this study was to verify whether prostaglandin analogue (PA) eye drops influence the retinal thickness of glaucomatous patients undergoing trabeculectomy (TRAB) surgery. We selected eyes of...

Detailed Description

Purpose: The aim of this study was to verify whether topical prostaglandin analogue (PA) influence the macular thickness of glaucomatous patients undergoing trabeculectomy (TRAB) with Mitomycin C (MMC...

Eligibility Criteria

Inclusion

  • Clinical Diagnose's of Primary Glaucoma
  • Primary Open Angle Glaucoma
  • Primary Closed Angle Glaucoma
  • Normal Pressure Glaucoma
  • Pigmentary Glaucoma
  • Pseudosfoliative Glaucoma)
  • Changes in the visual field
  • Typical defect compatible with glaucomatous lesion and/or typical anatomical impairment of the optic disc or retinal nerve fiber layer
  • Hoyt's sign
  • Optic disc cupping ratio greater than 0.7
  • Defect located in the neural rim or cupping asymmetry
  • Indication for TRAB with MMC at the physician's discretion (target IOP not established with maximum tolerable clinical medication or impossibility of using medication due to allergies and/or financial conditions)
  • The operated eyes needed a reduction in IOP by at least 20% in relation to the baseline IOP in the last postoperative period (PO30)
  • Absence of the use of any ocular hypotensive medication.

Exclusion

  • Any pathology that could interfere with the test results
  • cataract (crystalline opacity)
  • corneal edema (such as leucoma, ulcers, keratopathies)
  • poor quality of exams (≤ 5/10)
  • any past macular pathology (such as macular hole, diabetic maculopathy, age related macular disease);
  • Use of diamox
  • Advanced glaucoma with maximal therapy
  • Advanced glaucoma with impaired fixation
  • Any surgical complications including hypotonia (IOP \< 6 mmHg) at any assessment
  • Performing combined cataract and glaucoma surgery
  • History of cataract surgery less than 6 months ago
  • Need for surgical reintervention during follow-up for any reason
  • Need for reintroduction of topical antiglaucoma therapy.

Key Trial Info

Start Date :

January 4 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2023

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT06000280

Start Date

January 4 2021

End Date

March 31 2023

Last Update

August 22 2023

Active Locations (1)

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Centro de Referencia em Oftalmologia

Goiânia, Goiás, Brazil, 74605-020