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

NCT03166566 | Completed

• 1 other identifier: CAAE 0194.0.203.203.09
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

glaucoma; glaucoma surgery; glaucoma drainage device; glaucoma implant; blindness

Outcome Measures

Primary Outcomes (1)

• Change for baseline of intra-ocular pressure (Goldmann applanation tonometry)

  The criteria for IOP reduction success were 15 mmHg and a 20% reduction compared to the baseline preoperative IOP.

  on days 1, 3, 7, 14, and 30, once a month up to 6 months, and every 6 months from 6 months to 2 years.

Secondary Outcomes (8)

• Ocular pain intensity ratting change from baseline

  on days 1, 3, 7, 14, and 30, once a month up to 6 months, and every 6 months from 6 months to 2 years.

• Conjunctival discharge presence/absence change from baseline

  on days 1, 3, 7, 14, and 30, once a month up to 6 months, and every 6 months from 6 months to 2 years.

• Conjunctival erosion or retraction appearence after surgery

  on days 1, 3, 7, 14, and 30, once a month up to 6 months, and every 6 months from 6 months to 2 years.

• Corneal edema presence change from baseline

  on days 1, 3, 7, 14, and 30, once a month up to 6 months, and every 6 months from 6 months to 2 years.

• Anterior chamber depth (gonioscopy) change from baseline

  on days 1, 3, 7, 14, and 30, once a month up to 6 months, and every 6 months from 6 months to 2 years.

Study Arms (1)

laminar drainage implant surgery

OTHER

patients included and operated

Device: Laminar drainage implant surgery.

Interventions

Laminar drainage implant surgery. DEVICE

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.

laminar drainage implant surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 years or older with a painful blind eye refractory to clinical treatment and an intraocular pressure (IOP) ≥ 30 mmHg.

You may not qualify if:

• eyes with extensive conjunctival scarring, a disorganized anterior segment, or retinal detachment identified by ophthalmoscopy or B-scan ultrasonography.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Related Publications (5)

• Wolf A, Hod Y, Buckman G, Stein N, Geyer O. Use of Autologous Scleral Graft in Ahmed Glaucoma Valve Surgery. J Glaucoma. 2016 Apr;25(4):365-70. doi: 10.1097/IJG.0000000000000232.

  PMID: 25719229 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Christakis PG, Zhang D, Budenz DL, Barton K, Tsai JC, Ahmed IIK; ABC-AVB Study Groups. Five-Year Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study. Am J Ophthalmol. 2017 Apr;176:118-126. doi: 10.1016/j.ajo.2017.01.003. Epub 2017 Jan 17.

  PMID: 28104418 RESULT

• Thieme H, Choritz L, Schuart C, Wecke T. [Tube versus trabeculectomy study]. Ophthalmologe. 2013 Aug;110(8):728-32. doi: 10.1007/s00347-013-2840-z. German.

  PMID: 23873397 RESULT

• Aref AA, Gedde SJ, Budenz DL. Glaucoma Drainage Implant Surgery. Dev Ophthalmol. 2017;59:43-52. doi: 10.1159/000458485. Epub 2017 Apr 25.

  PMID: 28442686 RESULT

MeSH Terms

Conditions

Glaucoma; Blindness

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastião C. Sobrinho, Md, Ph.D

  Hospital São Geraldo-Universidade Federal de Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: co-advisor

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: March 1, 2011
• Primary Completion: December 2, 2015
• Study Completion: September 2, 2016
• Last Updated: May 25, 2017

Record last verified: 2017-05