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Eye surgery showdown: does tunnel direction affect lens fixation success?

NCT ID NCT07701980

Disease control Sponsor: Yuzuncu Yil University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study compares two ways of creating scleral tunnels during flanged intrascleral intraocular lens (IOL) fixation surgery, a procedure used when the eye's natural lens support is missing or damaged. Researchers are testing whether making the tunnel horizontally (parallel to the limbus) or vertically (perpendicular) leads to better visual accuracy and fewer complications over two years. The trial involves 107 adults with lens dislocation or aphakia (no lens capsule). The main goal is to see how many eyes achieve a refraction within half a diopter of the target.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
flanged intrascleral IOL fixation (Yamane technique) with horizontal or vertical scleral tunnel orientation
What this could lead to
If one tunnel orientation proves more accurate or safer, it could become the preferred surgical approach for this procedure, improving visual outcomes and reducing complications.
What could go wrong
This is a single-center study with 107 participants, so results may not apply broadly. The difference between orientations may be small or not clinically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

107 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with aphakia, crystalline lens luxation, or intraocular lens luxation in the absence of adequate capsular support who underwent flanged intrascleral IOL fixation surgery at a single tertiary referral centre between March 1, 2022, and March 1, 2025. All patients were aged 18 years or older and completed 24 months of follow-up.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Complicated aphakia defined as absence of adequate capsular support following cataract extraction, lens trauma, or previous lensectomy * Crystalline lens luxation defined as partial or complete displacement of the natural lens due to zonular weakness * Intraocular lens (IOL) luxation defined as partial or complete dislocation of a previously implanted IOL * Inadequate capsular support (\<180° of intact zonular or capsular support) * Ability to complete scheduled follow-up visits * Complete follow-up data available Exclusion Criteria: * Previous scleral buckling surgery within 6 months * Pars plana vitrectomy within 3 months * Active uveitis * Active endophthalmitis * Uncontrolled scleritis or scleral thinning * Corneal decompensation (endothelial cell density \<1000 cells/mm²) * Uncontrolled glaucoma (IOP \>25 mmHg despite maximum therapy) * History of penetrating keratoplasty, DALK, DSEK, or DMEK * History of corneal refractive surgery * Active proliferative diabetic retinopathy * Pregnancy or breastfeeding * Inability to complete 24-month follow-up

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Conditions

The condition(s) this trial relates to.

congenital primary aphakia lens subluxation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aphakia - no lens capsule Intraocular lens dislocation

Contacts and locations

Locations

  • SBU Van Training and Research Hospital

    Van, 65000, Turkey (Türkiye)