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Laminar Drainage Implant: Safety of a Novel Surgical Treatment for Refractory Glaucoma.

NCT03166566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-05-25

No results posted yet for this study

Summary

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.

Conditions

  • Glaucoma
  • Blindness, Acquired
  • End-Stage Glaucoma
  • Glaucoma Traumatic

Interventions

DEVICE

Laminar drainage implant surgery.

A clear corneal traction suture was placed to achieve superior-temporal quadrant exposure, where a 90° conjunctival fornix-based flap was made, associated with two radial relaxing incisions. A half-thickness scleral tunnel (4.5 mm from the limbus and 4.0 mm wide) was made using a crescent blade and a superior-temporal iridectomy was performed through . Then, the tunnel end was shunted to the AC using a 1.5-mm-wide blade with a sharp tip. The LDI was inserted into the scleral tunnel so that its tip was positioned in the AC periphery and the implant was anchored to the sclera using 7-0 polypropylene thread with two separate sutures. Next, fistula function was assessed by the aqueous humor leakage test at the scleral tunnel entry site. Then, the conjunctiva was repositioned and running sutures were performed with 7-0 polyglactin for the relaxing incisions and mattress sutures were performed in the limbus using 10-0 nylon.

Sponsors & Collaborators

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Sebastião C. Sobrinho, Md, Ph.D · Hospital São Geraldo-Universidade Federal de Minas Gerais

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-01
Primary Completion
2015-12-02
Completion
2016-09-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166566 on ClinicalTrials.gov