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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1
Centro de Referencia em Oftalmologia
Goiânia, Goiás, Brazil, 74605-020