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Study on Ex-PRESS Implantation Combined With Phacoemulsification in Primary Angle-closure Glaucoma

NCT ID: NCT03323138

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2018-12-30

Brief Summary

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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.

Detailed Description

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The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy mainly for patients with primary open-angle glaucoma.It has been proved to be as effective as trabeculectomy in a series of researches. However the early postoperative complication of Ex-PRESS implantation is less frequent compared with trabeculectomy. Ex-PRESS was designed initially for open angle glaucoma, gradually some scholars used it in refractory postpenetrating keratoplasty glaucoma and in vitrectomized glaucoma,which showed that Ex-PRESS shunt implantation was an effective procedure too. We analyzed the clinical efficacy and safety of combined phacoemulsification and Ex-PRESS implantation for PACG patients with cataract. Data was recorded before surgery and postoperatively at 1 week and 1, 3, 6, 12,18,24,30,36 months，which included intraocular pressure (IOP), best corrected visual acuity (BCVA), number of medications, complications, corneal endothelial cell density and anterior segment optical coherence tomography(AS-OCT). Efficacy was assessed by IOP values and success rates. Complete success was determined by IOP between 5 and 21mmHg without medications.

Conditions

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Glaucoma, Angle-Closure

Keywords

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Ex-PRESS glaucoma filtration surgery phacoemulsification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, interventional and monocentric study based in a university hospital setting
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ex-PRESS and phacoemulsification

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

Group Type EXPERIMENTAL

Ex-PRESS and phacoemulsification

Intervention Type PROCEDURE

Interventions

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Ex-PRESS and phacoemulsification

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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yin ying zhao

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ai wu Fang, MD

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

Locations

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Ophthalmology and Optometry Hospital , Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Nie, MD

Role: CONTACT

Phone: +86-0571-86795965

Email: [email protected]

Ai wu Fang, MD

Role: CONTACT

Phone: +86-0571-88068888

Email: [email protected]

Facility Contacts

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Li Nie, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 15513462 (View on PubMed)

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.

Reference Type RESULT
PMID: 16468549 (View on PubMed)

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.

Reference Type RESULT
PMID: 19243831 (View on PubMed)

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.

Reference Type RESULT
PMID: 23807352 (View on PubMed)

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.

Reference Type RESULT
PMID: 26674779 (View on PubMed)

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.

Reference Type RESULT
PMID: 24210765 (View on PubMed)

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.

Reference Type RESULT
PMID: 26643962 (View on PubMed)

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.

Reference Type RESULT
PMID: 27603352 (View on PubMed)

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.

Reference Type RESULT
PMID: 24247999 (View on PubMed)

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.

Reference Type RESULT
PMID: 22074705 (View on PubMed)

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.

Reference Type RESULT
PMID: 20306441 (View on PubMed)

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.

Reference Type RESULT
PMID: 19223790 (View on PubMed)

Other Identifiers

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NL-HZ

Identifier Type: -

Identifier Source: org_study_id