Absence of Capsule SupportNCT03817151

Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

An observational study of Absence of Capsule Support and Aphakia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support. Read more about this study

Who is it for?: Ages 10 to 80 years
Conditions the study is for: Absence of Capsule Support, Aphakia
What is being tested?: posterior chamber intraocular lens implantation
Type of treatment: Surgery or procedure
How many people: 21 participants
Where: 1 siteChina
Study dates: 1 Jan 2017to 1 Dec 2018
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: Patients who underwent transscleral sutured PCIOL implantation between January 2017 and August 2018, in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Who may be able to join

Patients who underwent transscleral suture fixation of PCIOL
Time between the primary surgeries was at least 3 months

Who cannot join

Active intraocular inflammation
The intraocular pressure (IOP) was higher than 25 mmHg
The endothelial cell count (ECC) was more than 1,200 cells/mm2

Trial locations and contacts

1 site in 1 country.

China1 site

Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.

Conditions: Absence of Capsule Support, Aphakia
Being tested: posterior chamber intraocular lens implantation
Medical subject headings: Aphakia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

posterior chamber intraocular lens implantationProcedure or surgery
patients who underwent transscleral sutured posterior chamber 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: 1day postoperation
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: 1 week postoperation
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: 1 month postoperation
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: 3 month postoperation
Visual function
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Measured: 1 day postoperation
Visual function
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Measured: 1 week postoperation
Visual function
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Measured: 1 month postoperation
Visual function
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Measured: 3 month postoperation

Secondary outcomes (5)

intraocular pressure
intraocular pressure
Measured: 1 day, 1 week, 1 month, and 3 month postoperation
PCIOL tilt degree
PCIOL tilt degree measured using Ultrasound biomicroscope
Measured: 3 month postoperation
PCIOL decentration degree
PCIOL tilt degree measured using Ultrasound biomicroscope
Measured: 3 month postoperation
endothelial cell count
endothelial cell count
Measured: 1 week, 1 month, and 3 month postoperation
anterior chamber depth
anterior chamber depth measured using Ultrasound biomicroscope
Measured: 3 month postoperation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20171 Dec 2018

First posted25 Jan 2019
Study start1 Jan 2017
Primary completion1 Aug 2018
Study completion1 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Absence of Capsule SupportStudies 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: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03817151
Sponsor's protocol ID: xuwen2017-022
Status last verified: Jan 2019
First submitted: 15 Jan 2019
Last updated: 25 Jan 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support
ClinicalTrials.gov ID: NCT03817151
Acronym / sponsor ID: xuwen2017-022
Conditions: Absence of Capsule Support, Aphakia
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 1 Aug 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 25 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.

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 10 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who underwent transscleral sutured PCIOL implantation between January 2017 and August 2018, in Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Key inclusion criteria (2 listed)

Patients who underwent transscleral suture fixation of PCIOL
Time between the primary surgeries was at least 3 months

Key exclusion criteria (3 listed)

Active intraocular inflammation
The intraocular pressure (IOP) was higher than 25 mmHg
The endothelial cell count (ECC) was more than 1,200 cells/mm2

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
posterior chamber intraocular lens implantationpatients who underwent transscleral sutured posterior chamber intraocular lens implantation	Procedure or surgery	–

Primary outcome

Visual function
Time frame: 1day postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
Visual function
Time frame: 1 week postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
Visual function
Time frame: 1 month postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
Visual function
Time frame: 3 month postoperation
Best corrected visual acuity (BCVA) measured using a decimal chart
Visual function
Time frame: 1 day postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Visual function
Time frame: 1 week postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Visual function
Time frame: 1 month postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart
Visual function
Time frame: 3 month postoperation
uncorrected distance visual acuity (UDVA) measured using a decimal chart

5 secondary outcomes

intraocular pressure
Time frame: 1 day, 1 week, 1 month, and 3 month postoperation
PCIOL tilt degree
Time frame: 3 month postoperation
PCIOL decentration degree
Time frame: 3 month postoperation
endothelial cell count
Time frame: 1 week, 1 month, and 3 month postoperation
anterior chamber depth
Time frame: 3 month postoperation

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 25 Jan 2019.
Individual participant dataSharing planned: No

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 Absence of Capsule Support and Aphakia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 3 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 25 Jan 2019. 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?

Visual function (time frame: 1day postoperation). The study lists 8 primary outcomes in all. 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 NCT03817151.

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 25 Jan 2019.