NCT03323138

Brief Summary

Primary angle-closure glaucoma (PACG) is common, phacotrabeculectomy is associated with a significant risk of complications.The Ex-PRESS shunt was introduced as a modification to trabeculectomy, with the theoretical advantages of reduced complications.Our purpose is to perform a prospective study to evaluate the clinical outcomes and safety of the Ex-PRESS shunt with cataract surgery for PACG patients coexisting cataract.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

5.5 years

First QC Date

October 24, 2017

Last Update Submit

October 25, 2017

Conditions

Glaucoma, Angle-Closure

Keywords

Ex-PRESSglaucomafiltration surgeryphacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure (IOP)

    In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

    36 months

Secondary Outcomes (6)

  • Intraocular pressure (IOP)

    2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.

  • Number of intraocular pressure lowering medications

    2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.

  • Best corrected visual acuity (BCVA)

    2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months.

  • Corneal endothelial cell density

    3 months

  • Anterior chamber distance(ACD)

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Ex-PRESS and phacoemulsification

EXPERIMENTAL

A treatment session of PACG coexisting cataract treated with phacoemulsification combined with P50 Ex-PRESS miniature glaucoma device (Alcon Laboratories, Fort Worth, Texas, USA).

Procedure: Ex-PRESS and phacoemulsification

Interventions

Ex-PRESS and phacoemulsificationPROCEDURE
Ex-PRESS and phacoemulsification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The presence of PACG, angle peripheral anterior synechia (PAS) more than 180 degrees.
  • An indication for glaucoma filtering surgery based on uncontrolled IOP or progressive vision field defect despite antiglaucoma medications.
  • Mean vision field defect greater than 15dB.
  • The presence of a clinically significant decrease of visual acuity as a result of cataract, usually BCVA less than 0.6.

You may not qualify if:

  • Patients unable to give informed consent.
  • Ocular infection or inflammation in the study eye in the 3 months prior to enrollment.
  • Intraocular surgery in the study eye in the 3 months prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology and Optometry Hospital , Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

Related Publications (12)

  • Lai JS, Tham CC, Lam DS. Incisional surgery for angle closure glaucoma. Semin Ophthalmol. 2002 Jun;17(2):92-9. doi: 10.1076/soph.17.2.92.14716.

    PMID: 15513462RESULT

  • Tham CC, Lai JS, Poon AS, Lai TY, Lam DS. Results of trabeculectomy with adjunctive intraoperative mitomycin C in Chinese patients with glaucoma. Ophthalmic Surg Lasers Imaging. 2006 Jan-Feb;37(1):33-41.

    PMID: 16468549RESULT

  • Tham CC, Kwong YY, Leung DY, Lam SW, Li FC, Chiu TY, Chan JC, Lam DS, Lai JS. Phacoemulsification versus combined phacotrabeculectomy in medically uncontrolled chronic angle closure glaucoma with cataracts. Ophthalmology. 2009 Apr;116(4):725-31, 731.e1-3. doi: 10.1016/j.ophtha.2008.12.054. Epub 2009 Feb 25.

    PMID: 19243831RESULT

  • Beltran-Agullo L, Trope GE, Jin Y, Wagschal LD, Jinapriya D, Buys YM. Comparison of visual recovery following ex-PRESS versus trabeculectomy: results of a prospective randomized controlled trial. J Glaucoma. 2015 Mar;24(3):181-6. doi: 10.1097/IJG.0b013e31829e1b68.

    PMID: 23807352RESULT

  • Gonzalez-Rodriguez JM, Trope GE, Drori-Wagschal L, Jinapriya D, Buys YM. Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up. Br J Ophthalmol. 2016 Sep;100(9):1269-73. doi: 10.1136/bjophthalmol-2015-307161. Epub 2015 Dec 16.

    PMID: 26674779RESULT

  • Netland PA, Sarkisian SR Jr, Moster MR, Ahmed II, Condon G, Salim S, Sherwood MB, Siegfried CJ. Randomized, prospective, comparative trial of EX-PRESS glaucoma filtration device versus trabeculectomy (XVT study). Am J Ophthalmol. 2014 Feb;157(2):433-440.e3. doi: 10.1016/j.ajo.2013.09.014. Epub 2013 Nov 7.

    PMID: 24210765RESULT

  • Zhang M, Li B, Sun Y. EX-PRESS and ahmed glaucoma valve in treatment of refractory glaucoma. Acta Ophthalmol. 2016 Aug;94(5):e382-3. doi: 10.1111/aos.12898. Epub 2015 Dec 8. No abstract available.

    PMID: 26643962RESULT

  • Liu B, Guo DD, Du XJ, Cong CY, Ma XH. Evaluation of Ex-PRESS implantation combined with phacoemulsification in primary angle-closure glaucoma. Medicine (Baltimore). 2016 Sep;95(36):e4613. doi: 10.1097/MD.0000000000004613.

    PMID: 27603352RESULT

  • Wagschal LD, Trope GE, Jinapriya D, Jin YP, Buys YM. Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy: 1-Year Results. J Glaucoma. 2015 Oct-Nov;24(8):624-9. doi: 10.1097/IJG.0000000000000029.

    PMID: 24247999RESULT

  • Marzette L, Herndon LW. A comparison of the Ex-PRESS mini glaucoma shunt with standard trabeculectomy in the surgical treatment of glaucoma. Ophthalmic Surg Lasers Imaging. 2011 Nov-Dec;42(6):453-9. doi: 10.3928/15428877-20111017-03.

    PMID: 22074705RESULT

  • Vetrugno M, Ferreri P, Sborgia C. Ex-PRESS miniature glaucoma device in vitrectomized eyes. Eur J Ophthalmol. 2010 Sep-Oct;20(5):945-7. doi: 10.1177/112067211002000521.

    PMID: 20306441RESULT

  • Kanner EM, Netland PA, Sarkisian SR Jr, Du H. Ex-PRESS miniature glaucoma device implanted under a scleral flap alone or combined with phacoemulsification cataract surgery. J Glaucoma. 2009 Aug;18(6):488-91. doi: 10.1097/IJG.0b013e31818fb44e.

    PMID: 19223790RESULT

MeSH Terms

Conditions

Glaucoma, Angle-ClosureGlaucoma

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Ai wu Fang, MD

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Nie, MD

CONTACT

+86-0571-86795965hehemao2003@163.com

Ai wu Fang, MD

CONTACT

+86-0571-88068888953736995@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, interventional and monocentric study based in a university hospital setting
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 26, 2017

Study Start

July 1, 2012

Primary Completion

January 1, 2018

Study Completion

December 30, 2018

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

CN(1)