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The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.
This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.
The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal Suture | Active Comparator | intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery |
|
| Muscle Suture | Active Comparator | intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined glaucoma surgery | Procedure | combined procedure with trabeculectomy and cataract removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP | the change in the level of intraocular pressure | baseline and twelve months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | the change in the best corrected visual acuity | baseline and twelve months after surgery |
| MRD | the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zofia Mariak, Prof | Medical University of Bialystok | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University | Bialystok | 15-089 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25803293 | Background | Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15. |
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De-identified data of each participant will be available on email request for all primary and secondary outcome measures
Data will be available on email request for six months after completing recruitment
e-mail request, after Data Access Agreement is sign
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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A prospective randomized trial with a 6 month follow-up period
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| baseline and twelve months after surgery |