Glaucoma EyeNCT03797846
Comparison of Fixation Suture Type in Glaucoma Surgery
A study testing combined glaucoma surgery in people with Glaucoma Eye and Glaucoma, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Eye, Glaucoma
- What is being tested?
- combined glaucoma surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 1 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III)
- primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic
- documented progression of loss of field of vision
- significant daily IOP fluctuations
- no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medications
Who cannot join
- no consent to participation in the study
- prior surgical and laser procedures in the area of the eye
- narrow- or closed-angle glaucoma
- post-inflammatory or post-traumatic secondary glaucoma
- chronic illness of the cornea or optic nerve
- advanced macular degeneration
Show all 9Show fewer
- active inflammatory process
- pregnancy
- systemic steroid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures
The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.
This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.
Read the detailed description
The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.
- Conditions
- Glaucoma Eye, Glaucoma
- Being tested
- combined glaucoma surgery
- Keywords
- ptosis, combined procedures, glaucoma, post-surgery complication
- Medical subject headings
- Glaucoma, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined glaucoma surgeryProcedure or surgery
combined procedure with trabeculectomy and cataract removal
| Study group | Role | What they receive |
|---|---|---|
| Corneal Suture | Active comparator | intraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery Receives: Procedure: combined glaucoma surgery |
| Muscle Suture | Active comparator | intraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery Receives: Procedure: combined glaucoma surgery |
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 twelve months after surgery
Secondary outcomes (2)
BCVA
the change in the best corrected visual acuity
Measured: baseline and twelve months after surgery
MRD
the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm
Measured: baseline and twelve 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 posted9 Jan 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma EyeStudies 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
- Model description
- A prospective randomized trial with a 6 month follow-up period
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Konopińska, Medical University of Bialystok
- Investigators
- Zofia Mariak, Prof, Study chair, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797846
- Sponsor's protocol ID
- 1771
- Status last verified
- Jul 2020
- First submitted
- 3 Jan 2019
- Last updated
- 14 Jul 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 on email request for all primary and secondary outcome measures
Publications
Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.
PubMed 25803293
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness and Safety of Eye Fixation Types During Combined Glaucoma Procedures
- ClinicalTrials.gov ID
- NCT03797846
- Acronym / sponsor ID
- 1771
- Conditions
- Glaucoma Eye, Glaucoma
- Keywords
- ptosis, combined procedures, glaucoma, post-surgery complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Jan 2019 (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 compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea.
This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.
Detailed description
The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective randomized trial with a 6 month follow-up period
| Arm | Type | Receives |
|---|---|---|
| Corneal Suture | Active comparator | Procedure: combined glaucoma surgeryintraoperative fixation with the suture in clear cornea qualified to the combined glaucoma surgery |
| Muscle Suture | Active comparator | Procedure: combined glaucoma surgeryintraoperative fixation with the bridle suture for superior rectus muscle qualified to the combined glaucoma surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III)
- primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic
- documented progression of loss of field of vision
- significant daily IOP fluctuations
- no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medications
Key exclusion criteria (9 listed)
- no consent to participation in the study
- prior surgical and laser procedures in the area of the eye
- narrow- or closed-angle glaucoma
- post-inflammatory or post-traumatic secondary glaucoma
- chronic illness of the cornea or optic nerve
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 |
|---|---|---|
| combined glaucoma surgerycombined procedure with trabeculectomy and cataract removal | Procedure or surgery | Corneal Suture, Muscle Suture |
Primary outcome
IOP
Time frame: baseline and twelve months after surgery
the change in the level of intraocular pressure
2 secondary outcomes
BCVA
Time frame: baseline and twelve months after surgery
MRD
Time frame: baseline and twelve 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 14 Jul 2020.
- Background: PubMed 25803293Li B, Zhang M, Liu W, Wang J. Comparison of Superior Rectus and Peripheral Lamellar Corneal Traction Suture during Trabeculectomy. Curr Eye Res. 2016;41(2):215-21. doi: 10.3109/02713683.2015.1009635. Epub 2015 Sep 15.
- Individual participant dataSharing planned: Yes. De-identified data of each participant will be available on 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.
Zofia Mariak, Prof study chair
Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined glaucoma surgery in people with Glaucoma Eye and Glaucoma, run by Medical University of Bialystok at 1 site in Poland.
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 5 inclusion and 9 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 twelve 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 NCT03797846, which also lists 1 linked publication.
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 14 Jul 2020.