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

Primary Purpose

Glaucoma, Angle-Closure

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ex-PRESS and phacoemulsification

About this trial

This is an interventional treatment trial for Glaucoma, Angle-Closure focused on measuring Ex-PRESS, glaucoma, filtration surgery, phacoemulsification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ophthalmology and Optometry Hospital , Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ex-PRESS and phacoemulsification

Arm Description

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

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP)

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

Secondary Outcome Measures

Intraocular pressure (IOP)

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

Number of intraocular pressure lowering medications

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

Best corrected visual acuity (BCVA)

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

Corneal endothelial cell density

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

Anterior chamber distance(ACD)

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

Angle opening distance(AOD500)

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

Full Information

NCT ID

NCT03323138

First Posted

October 24, 2017

Last Updated

October 25, 2017

Sponsor

Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03323138

Brief Title

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

Acronym

PACG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2012 (Actual)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wenzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Angle-Closure

Keywords

Ex-PRESS, glaucoma, filtration surgery, phacoemulsification

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ex-PRESS and phacoemulsification

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Ex-PRESS and phacoemulsification

Primary Outcome Measure Information:

Title

Intraocular pressure (IOP)

Description

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Intraocular pressure (IOP)

Description

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

Time Frame

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

Title

Number of intraocular pressure lowering medications

Description

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

Time Frame

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

Title

Best corrected visual acuity (BCVA)

Description

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

Time Frame

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

Title

Corneal endothelial cell density

Description

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

Time Frame

3 months

Title

Anterior chamber distance(ACD)

Description

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

Time Frame

3 months

Title

Angle opening distance(AOD500)

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Nie, MD

Phone

+86-0571-86795965

hehemao2003@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ai wu Fang, MD

Phone

+86-0571-88068888

953736995@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ai wu Fang, MD

Organizational Affiliation

Wenzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmology and Optometry Hospital , Wenzhou Medical University

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325027

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Nie, MD

Phone

+86-0571-86795959

nl@mail.eye.ac.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

15513462

Citation

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.

Results Reference

result

PubMed Identifier

16468549

Citation

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.

Results Reference

result

PubMed Identifier

19243831

Citation

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.

Results Reference

result

PubMed Identifier

23807352

Citation

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.

Results Reference

result

PubMed Identifier

26674779

Citation

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.

Results Reference

result

PubMed Identifier

24210765

Citation

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.

Results Reference

result

PubMed Identifier

26643962

Citation

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.

Results Reference

result

PubMed Identifier

27603352

Citation

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.

Results Reference

result

PubMed Identifier

24247999

Citation

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.

Results Reference

result

PubMed Identifier

22074705

Citation

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.

Results Reference

result

PubMed Identifier

20306441

Citation

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.

Results Reference

result

PubMed Identifier

19223790

Citation

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.

Results Reference

result

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

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