CataractNCT03955796
Performance of a Hydrophilic and a Hydrophobic Intraocular Lens of Similar Design
A study testing Hydrophobic IOL and Non-hydrophobic IOL in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Hydrophobic IOL and Non-hydrophobic IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 9 May 2019to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Written informed consent prior to surgery
Who cannot join
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathologies
- Previous ocular surgery or trauma
- Pregnancy (pregnancy test will be taken in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
About this study
Official title: Capsular Bag Performance of a Hydrophilic and a Hydrophobic Acrylic Intraocular Lens of Similar Design
Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric
Read the detailed description
Cataract surgery is nowadays considered a safe surgery with a short rehabilitation time for the patients. Two main problems arising post-surgically are the predictability and stability of the implanted intraocular lens (IOL) in the capsular back and the formation of posterior capsule opacification (PCO). The performance of the IOL in the capsular bag influences the anterior chamber depth (ACD), tilt and decentration of the IOL, as well as formation of PCO. The main source of error for calculation of IOL power is an inaccurate prediction of the post-surgical ACD resulting in short- or farsightedness. Furthermore, capsular fibrosis and phimosis can also lead to tilt and decentration of the intraocular lens.
PCO is one of the most frequent long-term complications after cataract surgery, occuring in about 12% after 1 year, in 21% after 3 years, and in 28% after 5 years post-surgically. PCO arises when lens epithelial cells (LECs) migrate and proliferate, growing in between the IOL and the posterior capsule, leading to decreased visual acuity.
Material and design of the IOL may have an effect on the formation of PCO. It is suggested that 360° square edge design and hydrophobic material of the IOL may help in the prevention of PCO.
Hence, the aim of this study is to evaluate the capsular bag performance of monofocal IOLs with different materials but similar design and their influence on PCO formation.
100 eyes of 50 patients will be included into this study. After randomization one eye is implanted with the hydrophilic IOL, whereas the other eye gets the aspherical IOL. Follow-up visits will be 1 - 2 hours and 1 week after the surgery, as well as 6 months, 12 months, and 24 months post-surgically. During this visit a slit lamp examination, measurement of the intraocular pressure, visual acuity assessment, biometrical measurements of the eye, retroillumination photography and analysis of tilt and decentration of the IOL using the purkinjemeter will be performed.
- Conditions
- Cataract
- Being tested
- Hydrophobic IOL, Non-hydrophobic IOL
- Keywords
- Cataract, cataract surgery, intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophobic IOLDevice
RayOne Hydrophobic Aspheric, hydrophobic IOL
Non-hydrophobic IOLDevice
RayOne Aspheric, non-hydrophobic IOL
| Study group | Role | What they receive |
|---|---|---|
| RayOne Hydrophobic Aspheric | Experimental | Patient will receive the hydrophobic IOL during cataract surgery Receives: Device: Hydrophobic IOL |
| RayOne Aspheric | Experimental | Patient will receive the non-hydrophobic IOL during cataract surgery Receives: Device: Non-hydrophobic IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber depth (ACD)
The change in anterior chamber depth (ACD) before and after surgery will be measured using the IOL Master 700 and compared between the two different IOLs
Measured: 24 months
Secondary outcomes (2)
Distance visual acuity
Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 meters and differences in refraction will be compared between the two IOLs
Measured: 24 months
Intraocular pressure
Intraocular pressure will be measured before and after surgery using non-contact-tonometry and differences will be compared between the two differen IOLs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start9 May 2019
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Why it stopped: Changes will be made in the design of one of the study IOLs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955796
- Sponsor's protocol ID
- Ray hydrophobic
- Status last verified
- Aug 2021
- First submitted
- 16 May 2019
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsular Bag Performance of a Hydrophilic and a Hydrophobic Acrylic Intraocular Lens of Similar Design
- ClinicalTrials.gov ID
- NCT03955796
- Acronym / sponsor ID
- Ray hydrophobic
- Conditions
- Cataract
- Keywords
- Cataract, cataract surgery, intraocular lens
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes will be made in the design of one of the study IOLs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the capsular bag performance of the RayOne Hydrophobic Aspheric with the RayOne Aspheric
Detailed description
Cataract surgery is nowadays considered a safe surgery with a short rehabilitation time for the patients. Two main problems arising post-surgically are the predictability and stability of the implanted intraocular lens (IOL) in the capsular back and the formation of posterior capsule opacification (PCO). The performance of the IOL in the capsular bag influences the anterior chamber depth (ACD), tilt and decentration of the IOL, as well as formation of PCO. The main source of error for calculation of IOL power is an inaccurate prediction of the post-surgical ACD resulting in short- or farsightedness. Furthermore, capsular fibrosis and phimosis can also lead to tilt and decentration of the intraocular lens.
PCO is one of the most frequent long-term complications after cataract surgery, occuring in about 12% after 1 year, in 21% after 3 years, and in 28% after 5 years post-surgically. PCO arises when lens epithelial cells (LECs) migrate and proliferate, growing in between the IOL and the posterior capsule, leading to decreased visual acuity.
Material and design of the IOL may have an effect on the formation of PCO. It is suggested that 360° square edge design and hydrophobic material of the IOL may help in the prevention of PCO.
Hence, the aim of this study is to evaluate the capsular bag performance of monofocal IOLs with different materials but similar design and their influence on PCO formation.
100 eyes of 50 patients will be included into this study. After randomization one eye is implanted with the hydrophilic IOL, whereas the other eye gets the aspherical IOL. Follow-up visits will be 1 - 2 hours and 1 week after the surgery, as well as 6 months, 12 months, and 24 months post-surgically. During this visit a slit lamp examination, measurement of the intraocular pressure, visual acuity assessment, biometrical measurements of the eye, retroillumination photography and analysis of tilt and decentration of the IOL using the purkinjemeter will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RayOne Hydrophobic Aspheric | Experimental | Device: Hydrophobic IOLPatient will receive the hydrophobic IOL during cataract surgery |
| RayOne Aspheric | Experimental | Device: Non-hydrophobic IOLPatient will receive the non-hydrophobic IOL during cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age-related bilateral cataract
- Age 21 or older
- Visual acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Written informed consent prior to surgery
Key exclusion criteria (3 listed)
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathologies
- Previous ocular surgery or trauma
- Pregnancy (pregnancy test will be taken in women of reproductive age)
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 |
|---|---|---|
| Hydrophobic IOLRayOne Hydrophobic Aspheric, hydrophobic IOL | Device | RayOne Hydrophobic Aspheric |
| Non-hydrophobic IOLRayOne Aspheric, non-hydrophobic IOL | Device | RayOne Aspheric |
Primary outcome
Anterior chamber depth (ACD)
Time frame: 24 months
The change in anterior chamber depth (ACD) before and after surgery will be measured using the IOL Master 700 and compared between the two different IOLs
2 secondary outcomes
Distance visual acuity
Time frame: 24 months
Intraocular pressure
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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 Hydrophobic IOL and Non-hydrophobic IOL in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Aug 2021. 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 Austria. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Anterior chamber depth (ACD) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2021.