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New device aims to sharpen cataract surgery results for prior laser patients

NCT ID NCT05254587

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called IOLMASTER 700 TK to see if it can more accurately measure the eye's curvature in people who had laser vision correction and now need cataract surgery. Researchers compared four different lens calculation methods in 155 adults. The goal was to improve how surgeons choose the right lens implant for better vision after cataract surgery.

What this could mean

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

Active substance
IOLMASTER 700 TK device
What this could lead to
If successful, this could help eye surgeons choose more accurate lens power for cataract patients who previously had laser vision correction, improving their vision after surgery.
What could go wrong
This is a completed observational study, not a treatment trial. Results may not apply to all patients or lens types, and the benefit is limited to measurement accuracy, not a cure.

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

155 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2024

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

Subjects that have had laser vision correction and cataract surgery (retrospective cohort) or have had laser vision correction surgery and are scheduled for cataract surgery (prospective cohort).

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: 1. Adults, 18 years of age or older at the time of cataract surgery. 2. Patient has had LVC and IOL cataract surgery within 3 years or is scheduled to undergo IOL cataract surgery performed for the treatment of visually significant cataracts. Note: The only IOLs permitted for use in this study are Monofocal (ZCBOO, LI61AO, SN60WF, SA60WF, MX60E) and Toric Lenses (Tecnis 2 ZCU, ZCT, SN6ATx, SA6ATx, MX60ET). 3. Best corrected distance visual acuity (BCDVA) potential of 20/30 or better (as measured by Retinal Acuity Meter (RAM) or Potential Acuity Meter (PAM). 4. Patients who have a manifest refraction that is myopic or hyperopic after previous LVC. 5. Patients that have biometric measurements (including Axial Length) for the IOL cataract surgery that were performed preoperatively with the IOLMaster700, including Barrett True K /TK. 6. Signed and received a copy of the signed written informed consent (pertain to the prospective subjects only). 7. For prospective patients, willingness and ability to comply with schedule for follow-up visits and postoperative evaluations. Exclusion Criteria: 1. Patients with a history of any of the following: 1. Corneal pathology - Epithelial Basement Membrane Dystrophy (EMBD), Irregular Astigmatism, Decentered LASIK/PRK, Radial Keratotomy (RK), Fuchs Dystrophy 2. Retinal pathology - Visually significant Epiretinal Membrane (ERM) with loss of foveal contour, Large/ Medium Drusen, Cystoid Macular Edema (CME), History of Retinal Detachment 3. Optic neuropathy 4. Advanced glaucoma 5. Amblyopia 6. Strabismus 7. Relative Afferent Pupillary Defect (RAPD) indicating an optic neuropathy. 2. Patients with a previous history of small incision lenticule extraction (SMILE) surgery and/or glaucoma filtering procedure (defined as tubes or trabeculectomy) other than photorefractive keratectomy (PRK) or LASIK. 3. Patient who had to undergo A-scan measurement to retrieve Axial Length (AL) values. 4. Patient has had LVC and IOL cataract surgery within 3 years or is scheduled to undergo IOL cataract surgery performed for the treatment of visually significant cataracts with the presence or intention of implanting a multifocal, extended depth of focus, accommodating and light adjustable lens (such as, but not limited to, TFAT / TFNT; DAT / DFT; ICB00/DIB/DIU/DAT; ZXT; DFW; SN6AD1; AT-50; RxSIGHT). 5. Patients in whom the study eye experiences any intraoperative surgical complications or complex cataract surgeries (vitrectomy, corneal suturing). 6. Patients with previous LVC where one eye was treated for myopia and the other eye was treated for hyperopia. 7. Patient is participating in another study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Advanced Vision Care

    Los Angeles, California, 90067, United States

  • Empire Eye & Laser Center

    Bakersfield, California, 93309, United States

  • MUSC Storm Eye Institute29425

    Charleston, South Carolina, 29425, United States

  • Ophthalmic Partners PC

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Solomon Eye Physicians and Surgeons

    Bowie, Maryland, 20716, United States

  • Virginia eye consultant

    Norfolk, Virginia, 23502, United States

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505, United States

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