IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorVienna Hospital Association

About this trial

After cataract surgery, the thin natural membrane that holds the artificial lens in place can slowly turn cloudy. This is called posterior capsule opacification. It makes vision blurry and can cause glare. The standard treatment is a short, painless laser procedure called Nd:YAG capsulotomy, which opens a small clear window in the cloudy membrane.

Opening this membrane changes the support structure around the artificial lens. Eye doctors do not agree on what happens next. Some studies found that the lens shifts slightly backward in the eye after the laser treatment, some found that it shifts forward, and some found no movement at all. It is also unclear whether such a small shift changes how well a person sees or the strength of their glasses. One reason for these mixed results may be that each study used a different imaging device, and these devices measure the depth of the front chamber of the eye in different ways.

This study measures the position of the artificial lens in the same eye with three different imaging devices, before and after the laser treatment. The devices are called IOLMaster 700, CASIA2, and Pentacam AXL. All three take detailed pictures of the front of the eye without touching it. The study team wants to find out whether the artificial lens moves after the laser treatment, how much it moves, whether any movement changes vision or the glasses prescription, and whether the three devices give matching results.

Who can take part

People who had cataract surgery at least three months ago, who now have a cloudy membrane behind the artificial lens, and whose eye doctor has already decided that the laser treatment is needed.

What taking part involves

Taking part does not change the laser treatment in any way. The decision to perform the treatment, the technique, and the laser settings are made by the treating doctor for medical reasons and are not influenced by the study. The study only adds extra measurements before and after the treatment.

There are three study visits:

* Visit 1, on the day of the laser treatment and before the laser is used. The extra measurements take about 30 to 45 minutes. * Visit 2, about one week after the treatment. The extra measurements take about 15 to 20 minutes. * Visit 3, about one month after the treatment. The extra measurements take about 30 to 45 minutes.

At each visit the study team checks how well you can see, measures the strength of glasses that gives you the sharpest vision, examines your eye with a slit lamp, measures the pressure inside your eye, and takes images with the imaging devices. All of these are standard eye examinations used in everyday clinical practice. Nothing is inserted into the eye, and there are no injections, no medicines, and no radiation. Drops to widen the pupil are not needed for the study.

Taking part is voluntary. You can stop at any time, without giving a reason and without any disadvantage for your medical care. Your laser treatment and all routine follow-up visits go ahead either way. There is no payment for taking part, and taking part brings no direct medical benefit. However, the detailed examination may reveal something that would not be noticed during routine follow-up, such as raised eye pressure. If this happens, you will be told and any necessary care will be arranged as part of your normal treatment at no extra cost.

Study data are stored under a study code instead of your name.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pseudophakic eye with visually significant posterior capsule opacification for which Nd:YAG laser posterior capsulotomy is clinically indicated, defined as a subjective visual complaint attributable to the opacification (reduced visual acuity, glare or reduced contrast) together with objectively documented opacification on slit-lamp examination

Previous uneventful phacoemulsification with in-the-bag implantation of a posterior chamber intraocular lens; no restriction on IOL model

At least 3 months between the cataract surgery and the baseline study visit

Age 18 years or older at enrolment

Disqualifiers

Complicated cataract surgery, including posterior capsule rupture, vitreous loss, zonular dialysis, sulcus intraocular lens placement, anterior vitrectomy, or any other deviation from standard in-the-bag implantation

Previous intraocular lens exchange, repositioning, or secondary piggyback implantation

Previous Nd:YAG posterior capsulotomy of the study eye

Previous corneal refractive surgery of the study eye

Trial population

Consecutive pseudophakic patients presenting to the Department of Ophthalmology, Klinik Hietzing, Vienna, Austria, with visually significant posterior capsule opacification for which Nd:YAG laser posterior capsulotomy is clinically indicated. Patients are identified through the routine clinical workflow: the cataract follow-up clinic, referrals from external ophthalmologists, and self-presentation with visual complaints consistent with posterior capsule opacification. Enrolment is consecutive and unselected with respect to IOL model, axial length, time since cataract surgery and morphology of the opacification, so that the cohort reflects the general population of pseudophakic eyes undergoing capsulotomy at the study centre. The decision to perform the capsulotomy is made independently of the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Nd:YAG laser posterior capsulotomy

    Procedure/Surgery

    Routine Nd:YAG laser posterior capsulotomy performed for visually significant posterior capsule opacification according to the department's standard clinical protocol. Indication, technique, energy settings and capsulotomy size are determined by the treating ophthalmologist and are not modified by the study. Procedural parameters are documented for analysis.

  • Anterior segment swept-source OCT

    Diagnostic test

    Non-contact anterior segment optical coherence tomography providing anterior chamber depth, anterior chamber angle and volume, automated three-dimensional IOL tilt and decentration, corneal tomography, pachymetry and pupil parameters. Primary device for the primary outcome measure.

  • Swept-source optical biometry

    Diagnostic test

    on-contact optical biometry providing anterior chamber depth, keratometry, total keratometry, axial length, central corneal thickness, white-to-white and pupillometry.

  • Scheimpflug-based anterior segment tomography

    Diagnostic test

    Scheimpflug-based anterior segment tomography providing anterior chamber depth, SimK, total corneal refractive power, true net power, posterior keratometry, pachymetry mapping, corneal irregularity indices, chamber angle and volume, and axial length.

  • Subjective manifest refraction

    Diagnostic test

    Autorefraction as starting value followed by subjective manifest refraction with Jackson cross-cylinder refinement, yielding sphere, cylinder, axis and spherical equivalent, plus uncorrected and best-corrected distance visual acuity in logMAR. The refractionist is masked to previous refraction values at the post-capsulotomy visits.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Pseudophakic Eyes Undergoing Nd:YAG Laser Posterior Capsulotomy5 interventions

Trial outcomes

Primary outcomes

1

Change in anterior chamber depth (ACD) measured by anterior segment swept-source OCT

ACD in millimetres, measured from the posterior corneal surface to the anterior IOL surface by automated CASIA2 segmentation. The change is calculated as ACD after capsulotomy minus ACD before capsulotomy. Positive values indicate posterior IOL displacement, negative values anterior displacement. Reported as mean change with standard deviation and 95% confidence interval, together with the proportion of eyes exceeding the pre-specified clinical relevance threshold of 0.05 mm in absolute value.

Time frame
Baseline (immediately before capsulotomy) and 1 month (plus or minus 7 days) after capsulotomy

Secondary outcomes

1

Change in IOL tilt measured by anterior segment swept-source OCT

Horizontal and vertical IOL tilt in degrees, measured with the CASIA2 post-operative cataract application. Reported as mean change with standard deviation and as the proportion of eyes with an absolute tilt change of at least 2 degrees.

Time frame
Baseline and 1 month after capsulotomy
2

Change in IOL decentration measured by anterior segment swept-source OCT

IOL decentration in millimetres, measured with the CASIA2 post-operative cataract application. Reported as mean change with standard deviation and as the proportion of eyes with an absolute change of at least 0.3 mm.

Time frame
Baseline and 1 month after capsulotomy
3

Change in spherical equivalent from standardized manifest refraction

Spherical equivalent in dioptres, calculated as sphere plus half the cylinder from subjective manifest refraction with Jackson cross cylinder refinement. Positive change indicates hyperopic shift.

Time frame
Baseline, 1 week and 1 month after capsulotomy
4

Proportion of eyes with a clinically relevant refractive shift

Proportion of eyes with an absolute change in spherical equivalent of at least 0.50 dioptres, reported with Wilson 95% confidence intervals.

Time frame
1 week and 1 month after capsulotomy

Other outcomes

Sponsors and contacts

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