Surgical and Refractive Outcomes of Combined Glaucoma Surgery

Glaucoma Clinical Trial

Official title:

Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335825
• Other study ID #: 1774
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Filtering Surgery
• Glaucoma
• Ocular Hypertension

Intervention

Procedure:
• phacotrabeculectomy
combined antiglaucoma procedure: trabeculectomy with phacoemulsification
• ExPress antiglaucoma surgery combined with phacoemulsification
combined antiglaucoma procedure: ExPress device implantation with phacoemulsification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

References & Publications (3)

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

Outcome

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