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

NCT06000280 | Completed

• 1 other identifier: CEROF
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 patients with glaucoma with surgical indication for TRAB who were using PA eye drops and without previous retinal alterations, from the Centro de Referência em Oftalmologia (CEROF) from the Federal University of Goiás and Fundação Banco de Olhos de Goiás (FUBOG). Patients were divided into 2 groups: the study group (SG) and the control group (CG). In the CG, the PA was suspended between 30 and 60 days before the preoperative exams were performed (maximum of 15 days before surgery for both groups). All patients included were submitted to various eye exams before the procedure, and postoperatively on 3 occasions: 1 to 3 days ("PO1"), 6 to 9 days ("PO7") and 27 to 30 days ("PO30") after surgery.

Conditions

Glaucoma

Keywords

prostaglandin analogue; macular edema; trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Previous use of prostaglandins does not change macular thickness after trabeculectomy

  The absolute variation of each variable of the macular parameters OCT in relation to the pre-op was performed and its comparison between the groups at different moments. There was equivalence in most of the evaluated comparisons. Considering the variation between pre-op and PO30, only the upper parafoveal thickness was statistically different between groups (p= 0.01). Taking into account the difference in percentage analyzing pre-op vs. PO30, only the superior parafoveal thickness showed statistical significance between groups (p=0.01).

  Measurements were performed at preop (up to 15 days before the intervention), 1 to 3 days ("PO1"), 6 to 9 days ("PO7") and 27 to 30 days ("PO30") after surgery.

Secondary Outcomes (1)

• The presence of the lens did not influence the correlations

  Measurements were performed at preop (up to 15 days before the intervention) and 27 to 30 days ("PO30") after surgery.

Study Arms (2)

Study group

ACTIVE COMPARATOR

The Study group refers to patients who are using topical prostaglandins analogues

Procedure: Trabeculectomy surgery

Control group

PLACEBO COMPARATOR

The Control group refers to patients who discontinued the use of topical prostaglandins analogues

Procedure: Trabeculectomy surgery

Interventions

Trabeculectomy surgery PROCEDURE

The Trabeculectomy aims to create a permanent drainage outflow channel for the aqueous humor, connecting the anterior chamber to the sub-Tenon's space, using mitomycin C consisted of opening the conjunctival base of the fornix and applying mitomycin C 0.4 mg/ml for 2 minutes. The trabeculectomy techniques require controlled outflow of aqueous humor through a sclerostomy and a partial-thickness scleral flap to form a subconjunctival bleb. The protected strength of the flap, with or without sutures, and the strength of the episcleral tissue determine the final IOP.

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals self-identified as male and female were eligible for the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

Centro de Referencia em Oftalmologia

Goiânia, Goiás, 74605-020, Brazil

Location

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Related Links

• Centro de Referencia em Oftalmologia

MeSH Terms

Conditions

Glaucoma; Macular Edema

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Officials

• Leopoldo Magacho dos Santos Silva, Doctor

  Universidade Federal de Goias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The techinician who performed the exams (Optical Coherence Tomography and Visual Field)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a randomized, prospective and comparative clinical trial. Both the surgeon (the only one) and the technician responsible for the exams were blinded to the study groups. The patients (one or both eyes) included were from the glaucoma outpatient clinic of the Fundação Banco de Olhos de Goiás (FUBOG) or the Reference Center in Ophthalmology (CEROF) of the Federal University of Goiás (UFG) between the years 202 and 2022. All patients with glaucoma with indication for Trab with MMC and in clinical use of any PA eye drops (latanoprost, travoprost, bimatoprost or tafluprost) in the eye to be operated on for at least 6 months were considered for inclusion. The study adhered to the principles of the Declaration of Helsinki and was authorized by the Research Ethics Committee of the UFG, under the Certificate of Presentation for Ethical Appreciation NUMBER 40055620.8.1001.5083. All those included voluntarily agreed to participate by signing the Free and Informed Consent Form.

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: January 4, 2021
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be shared 6 months after publication
• Access Criteria: Data sharing can be done after the consent of the main investigator of the study signed and sent by e-mail. Study principal investigator will review sharing requests

Locations

BR (1)