NCT06102109

Brief Summary

This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique. The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Sep 2023Sep 2028

Study Start

First participant enrolled

September 19, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

September 22, 2023

Last Update Submit

October 20, 2023

Conditions

Lens LuxationIOL SubluxationIOL OpacificationAphakia - No Lens Capsule

Keywords

Scleral fixated IOLYamane4 flanged technique

Outcome Measures

Primary Outcomes (2)

  • IOL tilt

    The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)

    3 years

  • IOL decentration

    The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)

    3 years

Secondary Outcomes (2)

  • Best corrected visual outcome

    12 weeks

  • Flange erosion and intrusion

    3 years

Study Arms (2)

Yamane Arm

ACTIVE COMPARATOR

Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.

Procedure: Pars plana vitrectomyProcedure: IOL explantationProcedure: Scleral IOL fixation Yamane Technique

"4-flanged" Arm

ACTIVE COMPARATOR

Scleral IOL fixation using the 4 flanged technique. A 4 loop haptic IOL (Physiol Micropure 123) gets fixated in the sclera using 6.0 polypropylene suture

Procedure: Pars plana vitrectomyProcedure: IOL explantationProcedure: Scleral IOL fixation "4-flanged" Technique

Interventions

Pars plana vitrectomyPROCEDURE

25gauge pars plana vitrectomy: to remove the vitreous if present

"4-flanged" ArmYamane Arm
IOL explantationPROCEDURE

Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity

"4-flanged" ArmYamane Arm
Scleral IOL fixation Yamane TechniquePROCEDURE

Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera using only its haptics, which are externalised 2.5mm behind the blue line. The haptic ends are flanged using a thermo cautery to prevent slipping back in.

Yamane Arm
Scleral IOL fixation "4-flanged" TechniquePROCEDURE

Scleral IOL fixation using the 4 flanged technique. A 4 loop haptic IOL (Physical Micropure 123) gets fixated in the sclera using one 6.0 polypropylene suture per 2 haptic loops, which are put trough the loops in a W shape. The suture ends are externalised 2.5mm behind the blue line and its ends are flanged using a thermo cautery to prevent slipping back in.

"4-flanged" Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Necessity for IOL (re)fixation in the absence of capsular support
  • willing to give informed consent and follow-up the duration of study

You may not qualify if:

  • Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
  • active inflammatory diseases of the eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Markus Schranz, Md

CONTACT

+4314040079690markus.schranz@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr.

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 26, 2023

Study Start

September 19, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

AU(1)