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Clinical Evaluation of the Adaptilens Accommodating IOL

NCT07607860 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-26

No results posted yet for this study

Summary

The goal of this feasibility study is to learn more about the performance of the intraocular lens device, if the device is safe for use and what the best surgical techniques are for implanting the product in patients who require correction of aphakia following phacoemulsification extraction of a senile cataract. The main questions it aims to answer are:

* Will the patient have any related complications?
* Will a patient's vision improve after surgery? Researchers will compare the eye treated with the investigational product with the eye treated with another product to see if there are any differences in vision and safety.
* Participants will be asked to attend all scheduled visits for the study, approximately 11 visits in total over 3 years.
* During these visits the participants will be asked about their medical history, have testing and measurements taken, and one visit that is the scheduled surgery.

The participants will be asked to use eye drops that have been prescribed by the doctor performing the surgery.

Conditions

  • Aphakia Cataract

Interventions

DEVICE

Accomodating Intra Ocular Lens

This lens is accommodating.

DEVICE

Monofocal Intra Ocular Lens

Monofocal lens

Sponsors & Collaborators

  • Adaptilens, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607860 on ClinicalTrials.gov