Assessment of Effectiveness Ex-Press Surgery Modification

NCT03800589 | Completed

• 1 other identifier: 15/WIM/2010
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.

Conditions

Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Primary Open Angle

Outcome Measures

Primary Outcomes (3)

• IOP

  the change in level of intraocular pressure

  baseline, and 24th month after surgery

• CDVA

  the change in corrected distance visual acuity

  baseline, and 24th month after surgery

• number of drugs

  the change in number of antiglaucoma medications

  baseline, and 24th month after surgery

Secondary Outcomes (1)

• number of complications

  in a day of surgery

Study Arms (2)

phaco and Ex-Press

ACTIVE COMPARATOR

patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press

Procedure: phacoemulsification with implantation of the Ex-Press

deep sclerectomy, phaco and Ex-press

ACTIVE COMPARATOR

patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation

Procedure: deep sclerectomy, phacoemulsification, ExPress implantation

Interventions

phacoemulsification with implantation of the Ex-Press PROCEDURE

The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.

phaco and Ex-Press

deep sclerectomy, phacoemulsification, ExPress implantation PROCEDURE

The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.

deep sclerectomy, phaco and Ex-press

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
• patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
• documented progression of loss of field of vision,
• significant daily IOP fluctuations,
• no cooperation from patient with regard to application of anti-glaucoma treatment,
• allergy to topical medication
• written consent to involvement and participation in the study for a period of at least 24 months

You may not qualify if:

• no consent to participation in the study
• prior surgical and laser procedures in the area of the eye
• narrow- or closed-angle glaucoma
• post-inflammatory or post-traumatic secondary glaucoma
• chronic illness of the cornea or optic nerve
• advanced macular degeneration
• active inflammatory process
• pregnancy
• systemic steroid therapy

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Related Publications (1)

• Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.

  PMID: 20552258 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Marek Rękas, Prof

  Military Institute of Medicine in Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized control study with 24-month follow-up.

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: December 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 18 months of study completion
• Access Criteria: Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement