Surgical and Refractive Outcomes of Combined Glaucoma Surgery
Primary Purpose
Glaucoma, Ocular Hypertension, Filtering Surgery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phacotrabeculectomy
ExPress antiglaucoma surgery combined with phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring glaucoma combined surgery, postoperative astigmatism, postsurgery refractive error
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
phacotrabeculectomy
ExPress device implantation
Arm Description
patients undergoing phacotrabeculectomy
patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification
Outcomes
Primary Outcome Measures
IOP
the change in the level of intraocular pressure
Secondary Outcome Measures
Best corrected visual acuity (BCVA)
the change in the best corrected visual acuity
astigmatism
the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery
Full Information
NCT ID
NCT04335825
First Posted
March 28, 2020
Last Updated
April 3, 2020
Sponsor
Medical University of Bialystok
1. Study Identification
Unique Protocol Identification Number
NCT04335825
Brief Title
Surgical and Refractive Outcomes of Combined Glaucoma Surgery
Official Title
Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension, Filtering Surgery
Keywords
glaucoma combined surgery, postoperative astigmatism, postsurgery refractive error
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phacotrabeculectomy
Arm Type
Active Comparator
Arm Description
patients undergoing phacotrabeculectomy
Arm Title
ExPress device implantation
Arm Type
Active Comparator
Arm Description
patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
phacotrabeculectomy
Intervention Description
combined antiglaucoma procedure: trabeculectomy with phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
ExPress antiglaucoma surgery combined with phacoemulsification
Intervention Description
combined antiglaucoma procedure: ExPress device implantation with phacoemulsification
Primary Outcome Measure Information:
Title
IOP
Description
the change in the level of intraocular pressure
Time Frame
baseline and six months after surgery
Secondary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA)
Description
the change in the best corrected visual acuity
Time Frame
baseline and six months after surgery
Title
astigmatism
Description
the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery
Time Frame
baseline and six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data of each participant will be available upon email request for all primary and secondary outcome measures
IPD Sharing Time Frame
Data will be available on email request for six months after completing the study
IPD Sharing Access Criteria
e mail request, after Data Access Agreement is sign
Citations:
PubMed Identifier
29177182
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.
Results Reference
result
PubMed Identifier
9640570
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.
Results Reference
result
PubMed Identifier
27621788
Citation
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.
Results Reference
result
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Surgical and Refractive Outcomes of Combined Glaucoma Surgery
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