Glaucoma Clinical Trial
Official title:
Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.
NCT number | NCT04335825 |
Other study ID # | 1774 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | December 30, 2019 |
Verified date | April 2020 |
Source | Medical University of Bialystok |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up
Status | Completed |
Enrollment | 81 |
Est. completion date | December 30, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery. - Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP >21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment. - Additional inclusion criteria were as follows: well documented progression of visual field defects, significant diurnal variations in the IOP, poor patient compliance, and allergy to topical drugs. Exclusion Criteria: - Lack of consent to participate in the study, - History of eye surgery or laser procedures within the eye, - Closed or narrow angle glaucoma, - Diabetes, - Advanced macular degeneration - Active inflammatory disease. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical University of Bialystok |
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IOP | the change in the level of intraocular pressure | baseline and six months after surgery | |
Secondary | Best corrected visual acuity (BCVA) | the change in the best corrected visual acuity | baseline and six months after surgery | |
Secondary | astigmatism | the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery | baseline and six months after surgery |
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