The IOL tilt comparison at 3 months after YAMANE scleral fixation IOL technique with stabilizer between AR40e and PU6AS Intraocular lens, A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241210004

Enrollment

Registered

2024-12-10

Start date

2024-12-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Intraocular lens tilt comparison at 3 months after YAMANE scleral fixation Intraocular lens technique with stabilizer between AR40e and PU6AS Intraocular lens, A pilot randomized controlled trial. YAMANE scleral fixation IOL, IOL tilt

Interventions

Use AR40e Intraocular lens model for YAMANE scleral fixation surgery,Use PU6AS Intraocular lens model for YAMANE scleral fixation surgery

Active Comparator Procedure/Surgery,Experimental Procedure/Surgery

AR40e,PU6AS

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aphakic eyes without adequate capsular support 2. Lens dislocation 3. Lens subluxation 4. Age more than 20 years

Exclusion criteria

Exclusion criteria: 1. High refractive errors - Myopia ( Spherical equivalents of more than -6 diopters ) - Hypermetropia ( Spherical equivalents of more than +3 diopters ) - Astigmatism ( Spherical equivalents of more than 3 diopters ) 2. Non-dilated pupil diameter > 4.5 mm 3. Poorly dilated pupil < 6 mm 4. Irregular pupil shape 5. Significant ocular comorbidities, such as corneal lesions, retinal diseases, uveitis, and glaucoma 6. History of open globe injury 7. Post scleral buckle patients 8. Patient who was no co-operate to perform any imaging or unable to evaluate visual acuity

Design outcomes

Primary

Measure	Time frame
Intraocular lens tilt angle 1 month and 3 months Scheimpflug image ( Pentacam )	—

Secondary

Measure	Time frame
Intraocular lens decentration in milimetres 1 month and 3 months Scheimpflug image ( Pentacam ),Prevalence of Intraocular lens tilt angle more than 5 degree 3 months Scheimpflug image ( Pentacam ),Visual Acuity 3 months EDTRS visual acuity chart,Postoperative complications 3 months Slit lamp , OCT,Preoperative and postoperative refraction 3 months Autorefration	—

Countries

Thailand

Contacts

Public ContactDirek Patikulsila

aculty of Medicine ,Chiang Mai University

dpatikulsila@gmail.com053935512

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026