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The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up
Trabeculectomy and implantation of the Ex-Press device belong to the same group of anti-glaucoma procedures improving subconjunctival outflow. The most frequently performed glaucoma surgery of choice is still trabeculectomy, although the less invasive implantation of the Ex-Press device is also an effective alternative. Despite the wide application of these two techniques, their impact on postoperative refraction is not entirely known. Quite often, in the early postoperative period there is a decrease in visual function, which is short-term, although there are reports that it can last up to a year after surgery. It can be caused by a reduction in IOP, as well as the direct effect of trabeculectomy on corneal topography, and thus on postoperative astigmatism and refractive error. The occurrence of astigmatism after trabeculectomy has been widely documented Combined operations of implanting the ExPress implant with cataract phacoemulsification differ from phacotrabeculectomy in that, they do not require cutting of the sclera, cutting the limbus and using a punch.
The purpose of our research was to compare the phacotrabeculectomy and phacoemulsification combined with Express device implantation in terms of incidence of postoperative astigmatism in a prospective randomized study, and to attempt to determine what factors determine its size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phacotrabeculectomy | Active Comparator | patients undergoing phacotrabeculectomy |
|
| ExPress device implantation | Active Comparator | patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phacotrabeculectomy | Procedure | combined antiglaucoma procedure: trabeculectomy with phacoemulsification |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP | the change in the level of intraocular pressure | baseline and six months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) | the change in the best corrected visual acuity | baseline and six months after surgery |
| astigmatism | the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29177182 | Result | Chan HHL, Kong YXG. Glaucoma surgery and induced astigmatism: a systematic review. Eye Vis (Lond). 2017 Nov 17;4:27. doi: 10.1186/s40662-017-0090-x. eCollection 2017. | |
| 9640570 | Result | Hong YJ, Choe CM, Lee YG, Chung HS, Kim HK. The effect of mitomycin-C on postoperative corneal astigmatism in trabeculectomy and a triple procedure. Ophthalmic Surg Lasers. 1998 Jun;29(6):484-9. |
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De-identified data of each participant will be available upon email request for all primary and secondary outcome measures
Data will be available on email request for six months after completing the study
e mail request, after Data Access Agreement is sign
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| 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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| ExPress antiglaucoma surgery combined with phacoemulsification | Procedure | combined antiglaucoma procedure: ExPress device implantation with phacoemulsification |
|
| baseline and six months after surgery |
| 27621788 | Result | Alvani A, Pakravan M, Esfandiari H, Safi S, Yaseri M, Pakravan P. Ocular Biometric Changes after Trabeculectomy. J Ophthalmic Vis Res. 2016 Jul-Sep;11(3):296-303. doi: 10.4103/2008-322X.188399. |
| D059708 | Ultrasonic Surgical Procedures |