Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation Without Conjunctival Dissection

Suture, Complication Clinical Trial

Official title:

Novel Use of an Adjustable Single 8-0 Polypropylene Suture of Scleral Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476264
• Other study ID #: TR2019IOL
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Suture, Complication

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