Suture, ComplicationNCT04476264
Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation Without Conjunctival Dissection
An observational study of Suture, Complication, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
1. observe the effectivity of an adjustable single 8-0 polypropylene suture to scleral fix without conjunctival dissection for the treatment with aphakia or inadequate posterior capsule support. 2. observe the complication of this surgery method. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suture, Complication
- What is being tested?
- Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Jul 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any participants who used an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection could be included.
Who may be able to join
- Any patients who used an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection could be included.
Who cannot join
- Data from patients with a < 6-month postoperative follow-up or with incomplete operative or postoperative medical records were excluded from this study. Enrolled patients had complete records pertaining to their visual acuity (VA), slit-lamp photographs, and ultrasound biomicroscope (UBM) findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation
- observe the effectivity of an adjustable single 8-0 polypropylene suture to scleral fix without conjunctival dissection for the treatment with aphakia or inadequate posterior capsule support.
- observe the complication of this surgery method.
- Conditions
- Suture, Complication
- Being tested
- Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissectionProcedure or surgery
The present study serves to describe a novel approach to utilizing a single adjustable 8-0 polypropylene suture for scleral fixation without conjunctival dissection and to evaluate safety and efficacy outcomes associated with this technique.
| Study group | Role | What they receive |
|---|---|---|
| transscleral IOL fixation | the use of a novel adjustable single 8-0 polypropylene suture for scleral fixation without conjunctival dissection Receives: Procedure: Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncorrected VA
preoperative and postoperative uncorrected VA
Measured: at 3 months postoperatively
Secondary outcomes (1)
Postoperative complications
Postoperative complications during the follow-up
Measured: follow up time is larger 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Apr 2018
- Primary completion1 Apr 2018
- Study completion30 Jul 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 Suture, ComplicationStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476264
- Sponsor's protocol ID
- TR2019IOL
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mo B, Li SF. Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection. BMC Ophthalmol. 2020 Jul 25;20(1):304. doi: 10.1186/s12886-020-01558-y.
PubMed 32711502
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation
- ClinicalTrials.gov ID
- NCT04476264
- Acronym / sponsor ID
- TR2019IOL
- Conditions
- Suture, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 20 Jul 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.
- observe the effectivity of an adjustable single 8-0 polypropylene suture to scleral fix without conjunctival dissection for the treatment with aphakia or inadequate posterior capsule support.
- observe the complication of this surgery method.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transscleral IOL fixation | – | Procedure: Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissectionthe use of a novel adjustable single 8-0 polypropylene suture for scleral fixation without conjunctival dissection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any participants who used an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection could be included.
Key inclusion criteria (1 listed)
- Any patients who used an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection could be included.
Key exclusion criteria (1 listed)
- Data from patients with a < 6-month postoperative follow-up or with incomplete operative or postoperative medical records were excluded from this study. Enrolled patients had complete records pertaining to their visual acuity (VA), slit-lamp photographs, and ultrasound biomicroscope (UBM) findings.
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 |
|---|---|---|
| Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissectionThe present study serves to describe a novel approach to utilizing a single adjustable 8-0 polypropylene suture for scleral fixation without conjunctival dissection and to evaluate safety and efficacy outcomes associated with this technique. | Procedure or surgery | transscleral IOL fixation |
Primary outcome
uncorrected VA
Time frame: at 3 months postoperatively
preoperative and postoperative uncorrected VA
1 secondary outcome
Postoperative complications
Time frame: follow up time is larger 6 month
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 20 Jul 2020.
- Derived from this study: PubMed 32711502Mo B, Li SF. Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection. BMC Ophthalmol. 2020 Jul 25;20(1):304. doi: 10.1186/s12886-020-01558-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suture, Complication, run by Beijing Tongren Hospital at 1 site in China.
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 1 inclusion and 1 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 20 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 China. 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?
uncorrected VA (time frame: at 3 months postoperatively). 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 NCT04476264, 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 20 Jul 2020.