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NCT03166566
Laminar Drainage Implant: Safety of a Novel Surgical Treatment for Refractory Glaucoma.
NA trial testing Laminar drainage implant surgery. in Glaucoma in 15 participants. Completed in 2 September 2016.
2 December 2015
Quick facts
| Lead sponsor | Federal University of Minas Gerais |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 15 |
| Start date | 1 March 2011 |
| Primary completion | 2 December 2015 |
| Estimated completion | 2 September 2016 |
Drugs / interventions tested
- Laminar drainage implant surgery.
Conditions studied
- Glaucoma — all drugs for Glaucoma →
- Blindness, Acquired — all drugs for Blindness, Acquired →
- End-Stage Glaucoma — all drugs for End-Stage Glaucoma →
- Glaucoma Traumatic — all drugs for Glaucoma Traumatic →
Sponsor
Federal University of Minas Gerais
Who can join
18 and older, any sex, with Glaucoma or Blindness, Acquired. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Purpose: To assess the feasibility of a surgical technique and present the preliminary safety results of a new glaucoma device devoid of a tube in painful blind eyes. Methods: Fifteen end-stage glaucomatous eyes without light perception vision were treated with a novel laminar drainage implant. Intraocular pressure was measured preoperatively and up to 24 months after surgery using a Goldmann applanation tonometer. A scale ranging from 0 to 10 was used to evaluate ocular pain. Conjunctival hyperemia, discharge, erosion or retraction, aqueous humor leakage, corneal edema, hyphema, anterior chamber cells and depth, dislocation of the implant, and filtering bleb height were assessed by slit-lamp biomicroscopy. Anterior segment optical coherence tomography was also assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03166566
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03166566 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of Minas Gerais
- Last refreshed: 25 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03166566.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing