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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04476264
Other study ID # TR2019IOL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date July 30, 2019

Study information

Verified date July 2020
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date July 30, 2019
Est. primary completion date April 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Any patients who used an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection could be included.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection
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.

Locations

Country Name City State
China Beijing Tongren Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other IOL and tunnel location IOL tunnels containing sutures were clearly visible by UBM at 2 months postoperatively
Primary uncorrected VA preoperative and postoperative uncorrected VA at 3 months postoperatively
Secondary Postoperative complications Postoperative complications during the follow-up follow up time is larger 6 month
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