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

NCT04476264 | Completed

• 1 other identifier: TR2019IOL
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.observe the complication of this surgery method.

Conditions

Suture, Complication

Outcome Measures

Primary Outcomes (1)

• uncorrected VA

  preoperative and postoperative uncorrected VA

  at 3 months postoperatively

Secondary Outcomes (1)

• Postoperative complications

  follow up time is larger 6 month

Other Outcomes (1)

• IOL and tunnel location

  at 2 months postoperatively

Study Arms (1)

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

Interventions

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

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.

transscleral IOL fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 32711502 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: April 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: July 30, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

CN (1)