MicrospherophakiaNCT04447157
The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
An observational study of Microspherophakia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Microspherophakia
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 20 Jun 2020
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A retrospective study was conducted on 9 patients (18 eyes) diagnosed with microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine from July 2016 to April 2020.
Who may be able to join
- Microspherophakia was diagnosed and lens diameter<9mm;
- The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
- Lens dislocated into the anterior chamber;
- Lens dislocation caused elevated intraocular pressure (IOP);
- The lens contacted the corneal endothelium;
- Cataract;
Show all 9Show fewer
- Corneal endothelial cell density>1000/mm2;
- The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；
- There was possible improvement in postoperative visual acuity measured by retinometer.
Who cannot join
- The lens is centered and the position of the lens is stable;
- Glasses can correct the vision obviously;
- The reason for the elevated IOP was independent with the lens;
- A high possibility of corneal decompensation after surgery;
- Fundus function was poor and it is not expected to improve the vision after surgery;
- Combined with other ocular diseases which were not suitable for IOL implantation;
- Combined with a systemic disease that the patient cannot tolerate the surgery.
About this study
By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.
- Conditions
- Microspherophakia
- Medical subject headings
- Microspherophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Microspherophakia | This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: 6 month postoperation
Visual function
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Measured: 6 month postoperation
Intraocular pressure
intraocular pressure measured using non-contact tonometer
Measured: 6 month postoperation
PCIOL tilt degree
PCIOL tilt degree measured using Ultrasound biomicroscope
Measured: 6 month postoperation
PCIOL decentration distance
PCIOL decentration distance measured using Ultrasound biomicroscope
Measured: 6 month postoperation
Endothelial cell density
Endothelial cell density was measured by specular microscopy
Measured: 6 month postoperation
Anterior chamber depth
Anterior chamber depth measured using Ultrasound biomicroscope
Measured: 6 month postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Jul 2016
- Primary completion10 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrospherophakiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447157
- Sponsor's protocol ID
- xuwen2020-465
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
- ClinicalTrials.gov ID
- NCT04447157
- Acronym / sponsor ID
- xuwen2020-465
- Conditions
- Microspherophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 25 Jun 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.
By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microspherophakia | – | –This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A retrospective study was conducted on 9 patients (18 eyes) diagnosed with microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine from July 2016 to April 2020.
Key inclusion criteria (9 listed)
- Microspherophakia was diagnosed and lens diameter<9mm;
- The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
- Lens dislocated into the anterior chamber;
- Lens dislocation caused elevated intraocular pressure (IOP);
- The lens contacted the corneal endothelium;
Key exclusion criteria (7 listed)
- The lens is centered and the position of the lens is stable;
- Glasses can correct the vision obviously;
- The reason for the elevated IOP was independent with the lens;
- A high possibility of corneal decompensation after surgery;
- Fundus function was poor and it is not expected to improve the vision after surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual function
Time frame: 6 month postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
Visual function
Time frame: 6 month postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Intraocular pressure
Time frame: 6 month postoperation
intraocular pressure measured using non-contact tonometer
PCIOL tilt degree
Time frame: 6 month postoperation
PCIOL tilt degree measured using Ultrasound biomicroscope
PCIOL decentration distance
Time frame: 6 month postoperation
PCIOL decentration distance measured using Ultrasound biomicroscope
Endothelial cell density
Time frame: 6 month postoperation
Endothelial cell density was measured by specular microscopy
Anterior chamber depth
Time frame: 6 month postoperation
Anterior chamber depth measured using Ultrasound biomicroscope
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 30 Jun 2020.
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?
An observational study of Microspherophakia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 9 inclusion and 7 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 30 Jun 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?
Visual function (time frame: 6 month postoperation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2020.