GlaucomaNCT04335825
Surgical and Refractive Outcomes of Combined Glaucoma Surgery
A study testing phacotrabeculectomy and ExPress antiglaucoma surgery combined with phacoemulsification in people with Glaucoma and Ocular Hypertension, run by Medical University of Bialystok.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Filtering Surgery
- What is being tested?
- phacotrabeculectomy and ExPress antiglaucoma surgery combined with phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.
The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up
Read the 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.
- Conditions
- Glaucoma, Ocular Hypertension, Filtering Surgery
- Being tested
- phacotrabeculectomy, ExPress antiglaucoma surgery combined with phacoemulsification
- Keywords
- glaucoma combined surgery, postoperative astigmatism, postsurgery refractive error
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacotrabeculectomyProcedure or surgery
combined antiglaucoma procedure: trabeculectomy with phacoemulsification
ExPress antiglaucoma surgery combined with phacoemulsificationProcedure or surgery
combined antiglaucoma procedure: ExPress device implantation with phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| phacotrabeculectomy | Active comparator | patients undergoing phacotrabeculectomy Receives: Procedure: phacotrabeculectomy |
| ExPress device implantation | Active comparator | patients undergoing ExPress antiglaucoma surgery combined with phacoemulsification Receives: Procedure: ExPress antiglaucoma surgery combined with phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
the change in the level of intraocular pressure
Measured: baseline and six months after surgery
Secondary outcomes (2)
Best corrected visual acuity (BCVA)
the change in the best corrected visual acuity
Measured: baseline and six months after surgery
astigmatism
the change in the value of astigmatism with the use of autokeratorefractometer before and after surgery
Measured: baseline and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jan 2016
- Primary completion1 Jan 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335825
- Sponsor's protocol ID
- 1774
- Status last verified
- Apr 2020
- First submitted
- 28 Mar 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data of each participant will be available upon email request for all primary and secondary outcome measures
Publications
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.
PubMed 29177182Hong 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.
PubMed 9640570Alvani 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.
PubMed 27621788
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Refractive Outcomes of Combined Phaco-ExPress Versus Phacotrabeculectomy - 6 Months Results.
- ClinicalTrials.gov ID
- NCT04335825
- Acronym / sponsor ID
- 1774
- Conditions
- Glaucoma, Ocular Hypertension, Filtering Surgery
- Keywords
- glaucoma combined surgery, postoperative astigmatism, postsurgery refractive error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phacotrabeculectomy | Active comparator | Procedure: phacotrabeculectomypatients undergoing phacotrabeculectomy |
| ExPress device implantation | Active comparator | Procedure: ExPress antiglaucoma surgery combined with phacoemulsificationpatients undergoing ExPress antiglaucoma surgery combined with phacoemulsification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacotrabeculectomycombined antiglaucoma procedure: trabeculectomy with phacoemulsification | Procedure or surgery | phacotrabeculectomy |
| ExPress antiglaucoma surgery combined with phacoemulsificationcombined antiglaucoma procedure: ExPress device implantation with phacoemulsification | Procedure or surgery | ExPress device implantation |
Primary outcome
IOP
Time frame: baseline and six months after surgery
the change in the level of intraocular pressure
2 secondary outcomes
Best corrected visual acuity (BCVA)
Time frame: baseline and six months after surgery
astigmatism
Time frame: baseline and six months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Results publication: PubMed 29177182Chan 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 publication: PubMed 9640570Hong 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 publication: PubMed 27621788Alvani 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.
- Individual participant dataSharing planned: Yes. De-identified data of each participant will be available upon email request for all primary and secondary outcome measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing phacotrabeculectomy and ExPress antiglaucoma surgery combined with phacoemulsification in people with Glaucoma and Ocular Hypertension, run by Medical University of Bialystok.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: baseline and six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335825, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.