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| ID | Type | Description | Link |
|---|---|---|---|
| 76/WIM/015 | Other Identifier | MMI |
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It is a comparative study of Safety and Efficacy of Three Variants of Canaloplasty: ab-externo, ab-interno and minicanaloplasty. Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| canaloplasty ab externo and phacoemulsification | Active Comparator | As soon as the two scleral flaps: deep and superficial -similar to deep sclerectomy are dissected, the phacoemulsification with PCIOL insertion is performed. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and guided for 360 degrees within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. Then a suture is tied to the distal tip and the microcatheter is withdrawn. As it appears at the other ostium of canal the microcatheter it separated from the suture.Then suture loop is tightened to tension the trabecular meshwork. The superficial flap is sutured watertight to prevent bleb formation |
|
| canaloplasty ab interno and phacoemulsification | Active Comparator | This variant of canaloplasty spares conjunctival surface. First phacoemulsification and PCIOL placement is performed. The Schlemm's canal is reached through goniotomy through anterior chamber. Similarly microcatheter is inserted and viscodilatator applicated. The key difference, is that no tensioning suture is left after the catheter is withdrawn. phacoemulsification is performed. |
|
| minicanaloplasty and phacoemulsification | Active Comparator | The dissected conjunctival flap is of minimal size. The scleral flaps are sized: superficial flap 3x1mm, and deep flap: 1x1 mm- with no removal of the deep flap. Afterwards phacoemulsification part is performed. The microcatheterization and viscodilatation are conducted as in the traditional procedure.The conjunctiva is closed with one suture or coagulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canaloplasty and phacoemulsification | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean IOP | change form baseline at 24 months | |
| Number of antiglaucoma drugs | change from baseline at 24 months | |
| intraoperative complications | at the day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity | change from baseline at 24 months | |
| Visual Field changes | MD, | change from baseline at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marek Rękas, MD, PhD, Professor | Contact | +48604113659 | rekaspl@gmail.com | |
| Aleksandra Kicińska, MD | Contact | +48601339376 | aleksandra.kicinska@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Institute of Medicine | Recruiting | Warsaw | 04-141 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31377849 | Derived | Danielewska ME, Kicinska AK, Placek MM, Lewczuk K, Rekas M. Changes in spectral parameters of corneal pulse following canaloplasty. Graefes Arch Clin Exp Ophthalmol. 2019 Nov;257(11):2449-2459. doi: 10.1007/s00417-019-04433-9. Epub 2019 Aug 3. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens 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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| Early and Late postsurgical complications |
| within 24 months |
| % IOP reduction | change at 24 months from baseline |
| D059708 | Ultrasonic Surgical Procedures |