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

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

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.

Study Overview

• Status: Completed
• Conditions: Suture, Complication
• Intervention / Treatment: Procedure: Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
transscleral IOL fixation; the use of a novel adjustable single 8-0 polypropylene suture for scleral fixation without conjunctival dissection	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uncorrected VA	preoperative and postoperative uncorrected VA	at 3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications during the follow-up	follow up time is larger 6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOL and tunnel location	IOL tunnels containing sutures were clearly visible by UBM	at 2 months postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TR2019IOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No