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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ex-PRESS and phacoemulsification | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer | 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months. |
| Number of intraocular pressure lowering medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Nie, MD | Contact | +86-0571-86795965 | hehemao2003@163.com | |
| Ai wu Fang, MD | Contact | +86-0571-88068888 | 953736995@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ai wu Fang, MD | Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology and Optometry Hospital , Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15513462 | Result | 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. | |
| 16468549 | Result | 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. |
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| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Prospective, interventional and monocentric study based in a university hospital setting
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Number of drops and oral medications used by the patient compared to baseline |
| 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months. |
| Best corrected visual acuity (BCVA) | Number of lines reduction or improvement from baseline on Snellen acuity chart | 2 weeks, 1 month, 3 months, 6 months, 12 months,18 months, 24 months, 30 months,36 months. |
| Corneal endothelial cell density | Use non-contact specular microscope to count the endothelial cell density (cells/mm2) | 3 months |
| Anterior chamber distance(ACD) | The distance from inner corneal surface to lens measured by AS-OCT | 3 months |
| Angle opening distance(AOD500) | Angle opening distance 500um from the scleral spur measured by AS-OCT | 3 months |
| 19243831 | Result | 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. |
| 23807352 | Result | 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. |
| 26674779 | Result | 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. |
| 24210765 | Result | 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. |
| 26643962 | Result | 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. |
| 27603352 | Result | 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. |
| 24247999 | Result | 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. |
| 22074705 | Result | 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. |
| 20306441 | Result | 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. |
| 19223790 | Result | 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. |
| D059708 | Ultrasonic Surgical Procedures |