HyperopiaNCT00348205

A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia

A study testing Technolas 217z Zyoptix Laser in people with Hyperopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperopia, Astigmatism
What is being tested?: Technolas 217z Zyoptix Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Jun 2005to Mar 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hyperopia with or without astigmatism.

Who cannot join

Contraindications to LASIK.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb
Rochester, New York, 14609

Other trials in United States

About this study

A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Conditions: Hyperopia, Astigmatism
Being tested: Technolas 217z Zyoptix Laser
Medical subject headings: Hyperopia, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Technolas 217z Zyoptix LaserDevice
Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.

Study groups in NCT00348205
Study group	Role	What they receive
Technolas 217z Zyoptix System	Experimental	Bausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software. Receives: Device: Technolas 217z Zyoptix Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months
Measured: 24 months
Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Measured: 12 months
The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Measured: 24 months
Refractive Stability - Categorical Change Between Month 1 and Month 3
Percentage of eyes with a change of ≤ 1.00 Diopter in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Measured: Month 1, Month 3
Refractive Stability - Mean Change Between Month 1 and Month 3
Mean change in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Measured: 1 month, 3 months
Induced Astigmatism
Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.
Measured: 24 months

Secondary outcomes (1)

Loss of Best Spectacle-corrected Visual Acuity (BSCVA)
Percentage of eyes with loss of best spectacle corrected visual acuity (BSCVA) of >2 lines. Mean change in best-corrected high contrast distance visual acuity. Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity was averaged across visits.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Mar 2009

First posted4 Jul 2006 (estimated)
Study startJun 2005
Primary completionJan 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00348205
Sponsor's protocol ID: 369
Status last verified: Sep 2020
First submitted: 30 Jun 2006
Last updated: 14 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors

All Hyperopia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
ClinicalTrials.gov ID: NCT00348205
Acronym / sponsor ID: 369
Conditions: Hyperopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Jan 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 4 Jul 2006 (estimated)
Results: Posted 14 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Technolas 217z Zyoptix System	Experimental	Device: Technolas 217z Zyoptix LaserBausch \& Lomb Technolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Hyperopia with or without astigmatism.

Key exclusion criteria (1 listed)

Contraindications to LASIK.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Technolas 217z Zyoptix LaserTechnolas 217z Zyoptix System with Treatment Planner Customized Treatment Calculation Software for the wavefront-guided LASIK treatment of hyperopia and hyperoptic astigmatism.	Device	Technolas 217z Zyoptix System

Primary outcome

Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months
Time frame: 24 months
Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.
Time frame: 12 months
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia
Time frame: 24 months
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Refractive Stability - Categorical Change Between Month 1 and Month 3
Time frame: Month 1, Month 3
Percentage of eyes with a change of ≤ 1.00 Diopter in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Refractive Stability - Mean Change Between Month 1 and Month 3
Time frame: 1 month, 3 months
Mean change in manifest refraction spherical equivalent (MRSE) between postoperative refractions, performed at 1 months and 3 months after surgery. Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis. Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina. Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder. It is expressed in diopters (D).
Induced Astigmatism
Time frame: 24 months
Percentage of eyes which had >2.00 Diopter of induced refractive cylinder for those eyes treated for spherical hyperopia only.

1 secondary outcome

Loss of Best Spectacle-corrected Visual Acuity (BSCVA)
Time frame: 24 months

Results and safety

Results posted to the registry on 14 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Technolas 217z Zyoptix System	80	78

Primary outcome: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months

Time frame: 24 months. Count of units. Unit: eyes

Measure	Technolas 217z Zyoptix System n = 74
12 months	147
24 months	140

Population analysed: The number of eyes available for uncorrected visual acuity assessment at 12 months and 24 months were included in the analysis.

Primary outcome: Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.

Time frame: 12 months. Count of units. Unit: eyes

Measure	Technolas 217z Zyoptix System n = 74
Within 0.50 D	100
Within 1.00 D	142

Population analysed: The number of eyes available for manifest refraction spherical equivalent assessment at 12 months were included in the analysis.

Primary outcome: The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia

Time frame: 24 months. Count of units. Unit: eyes

Measure	Technolas 217z Zyoptix System n = 72
Within 0.50 D	97
Within 1.00 D	129

Population analysed: The number of eyes available for manifest refraction spherical equivalent assessment at 24 months were included in the analysis.

Primary outcome: Refractive Stability - Categorical Change Between Month 1 and Month 3

Time frame: Month 1, Month 3. Count of units. Unit: eyes

Measure	Technolas 217z Zyoptix System n = 70
Value	135

Population analysed: There were 139 eyes with manifest refraction spherical equivalent assessments at both Month 1 and Month 3 for this outcome assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Technolas 217z Zyoptix System	1 of 80 (1.3%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperopia

Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Technolas 217z Zyoptix Laser in people with Hyperopia and Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00348205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.