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Evaluation of retinal thickness in patients with Glaucoma using Prostaglandin eye drops undergoing Trabeculectomy surgery

Evaluation of Macular Thickness in patients with Glaucoma in use of Prostaglandin Analogue undergoing Trabeculectomy with Mitomycin C

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5y44mmj
Enrollment
Unknown
Registered
2023-09-30
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Interventions

Patients were selected from FUBOG (Fundação Banco de Olhos de Goiás) and CEROF-UFG (Centro de Referência em Oftalmologia - Universidade Federal de Goiás), using prostagandin analogues in the preopera
D10.251.355.255.550.775

Sponsors

Universidade Federal de Goiás
Lead Sponsor
Fundação Banco de Olhos de Goiás
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Pacients of all ages with Primary Glaucoma; Primary Open Angle Glaucoma; Primary Narrow Angle Glaucoma; Normal Pressure Glaucoma; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma; visual field changes; typical defect compatible with glaucomatous lesion and/or typical anatomical involvement of the optic disc or nerve fiber layer of the retina (such as Hoyt´s sign, cupping ratio greater than 0.7, localized neural rhyme defect, or cupping asymmetry); indication of trabeculectomy at medical discretion (example: uncontrolled intraocular pressure or impossibility of using medication due to allergy or financial conditions); need to reduce the intraocular pressure by at least 20% in relation to the baseline in the postoperative period for inclusion; intraocular pressure above the traget established for the case and with medication

Exclusion criteria

Exclusion criteria: Any pathology that could interfere with the results of the tests; low quality of exams; any previous macular pathology; use of diamox; advanced glaucoma with maximal therapy; advanced glaucoma with impaired fixation; any surgical complications including hypotonia in any evaluation; performing combined cataract and glaucoma surgery; need for surgical intervention; reintrodution of therapy with prostaglandin analogues

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: Evaluate changes in macular thickness in both groups, in use and not prostaglandin analogue eye drops, after surgery to reduce intraocular pressure during postoperative follow-up using Optical Coherence Tomography by means of delta variations, delta percentages, correlations of macular parameters with intraocular pressure at different times. It is expected do observe that in delta, delta percentages and in correlations between the groups there is no p value with statistical significance between them.;Outcome found 1: Evaluate changes in macular thickness were in both groups, in use and not prostaglandin analogue eye drops, after surgery to reduce intraocular pressure during postoperative follow-up using Optical Coherence Tomography by means of delta variations, delta percentages, correlations of macular parameters with intraocular pressure at different times. It was found in delta and delta percentage p values with statistical significance ( p= 0,013 and p= 0,011, respectivaly) in the upper macular thickness parameter between groups. e of p that the use of prostaglandin analogues before surgery did not demonstrate clinical significance or impact on postoperative macular thicknesses. The statistically difference found between the groups was very small, within the very coefficient variation of the Optical Coherence Tomography device. In the correlation test, no differences were found between the groups.

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactSula Britto

Centro de Referência em Oftalmologia

sulacabs@gmail.com+556232096770

Outcome results

None listed

Source: REBEC (via WHO ICTRP)