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Glaucoma, Angle-ClosurePACGNCT03323138

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

A study testing Ex-PRESS and phacoemulsification in people with Glaucoma, Angle-Closure, run by Wenzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Angle-Closure
What is being tested?
Ex-PRESS and phacoemulsification
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jul 2012to 30 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Li Nie, MD contact

+86-0571-86795965

hehemao2003@163.com

Ai wu Fang, MD contact

+86-0571-88068888

953736995@qq.com

China1 site, 1 recruiting

  • Ophthalmology and Optometry Hospital , Wenzhou Medical University

    Wenzhou, Zhejiang, 325027

    Li Nie, MD, +86-0571-86795959, nl@mail.eye.ac.cn

    Recruiting

Other trials in China

About this study

Official title: Prospective Study on Ex-PRESS Implantation Combined With Phacoemulsification in Primary Angle-closure Glaucoma

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.

Read the detailed description

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.

Being tested
Ex-PRESS and phacoemulsification
Keywords
Ex-PRESS, glaucoma, filtration surgery, phacoemulsification
Medical subject headings
Glaucoma, Angle-Closure, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ex-PRESS and phacoemulsificationProcedure or surgery

Study groups in NCT03323138
Study groupRoleWhat they receive
Ex-PRESS and phacoemulsificationExperimentalA treatment session of PACG coexisting cataract treated with phacoemulsification combined with P50 Ex-PRESS miniature glaucoma device (Alcon Laboratories, Fort Worth, Texas, USA).
Receives: Procedure: Ex-PRESS and phacoemulsification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraocular pressure (IOP)

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

    Measured: 36 months

Secondary outcomes (6)

  1. Intraocular pressure (IOP)

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

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

  2. Number of intraocular pressure lowering medications

    Number of drops and oral medications used by the patient compared to baseline

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

  3. Best corrected visual acuity (BCVA)

    Number of lines reduction or improvement from baseline on Snellen acuity chart

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

  4. Corneal endothelial cell density

    Use non-contact specular microscope to count the endothelial cell density (cells/mm2)

    Measured: 3 months

  5. Anterior chamber distance(ACD)

    The distance from inner corneal surface to lens measured by AS-OCT

    Measured: 3 months

  6. Angle opening distance(AOD500)

    Angle opening distance 500um from the scleral spur measured by AS-OCT

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2017
  2. Study start1 Jul 2012
  3. Primary completionJan 2018 (estimated)
  4. Study completion30 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, interventional and monocentric study based in a university hospital setting
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03323138
Sponsor's protocol ID
NL-HZ
Acronym
PACG
Status last verified
Oct 2017
First submitted
24 Oct 2017
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15513462

  • 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.

    PubMed 16468549

  • 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.

    PubMed 19243831

  • 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.

    PubMed 23807352

  • 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.

    PubMed 26674779

  • 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.

    PubMed 24210765

  • 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.

    PubMed 26643962

  • 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.

    PubMed 27603352

  • 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.

    PubMed 24247999

  • 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.

    PubMed 22074705

  • 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.

    PubMed 20306441

  • 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.

    PubMed 19223790

Questions about this trial

What is this clinical trial studying?

A study testing Ex-PRESS and phacoemulsification in people with Glaucoma, Angle-Closure, run by Wenzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Nie, MD (+86-0571-86795965, hehemao2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular pressure (IOP) (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03323138, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017; AzTrials last refreshed its copy on 1 Nov 2026.

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