Refractive ErrorsNCT04783909
Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome
An observational study of Refractive Errors and Cataract, run by Medical University of Lublin.
Trial summary
To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Cataract
- What is being tested?
- Phacoemulsification cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 May 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients above 18 yo with senile cataract with/without PEX without coexisting ocular pathologies
Who may be able to join
- senile cataract with/without PEX
Who cannot join
- corneal pathology
- glaucoma,
- corneal astigmatism greater than 2.0 diopters (D),
- previous eye surgery or subjects with decreased vision due to other reasons than cataract (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases),
- intraoperative complications,
- postoperative corrected distance visual acuity (CDVA) worse than 20/40,
Show all 9Show fewer
- axial length below 21 mm and above 25 mm,
- dense cataracts or poor fixation requiring ultrasound biometry
- eyes with manifest iridophacodonesis and those in which a capsular tension ring was inserted
About this study
Official title: Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome
To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX.
Read the detailed description
The primary outcome measure was to compare refractive outcomes (MAE, MedAE, percentage of eyes within certain range of prediction error) in PEX and control eyes. The secondary outcome measure was to determine whether any of IOL power prediction formulas (SRK/T, Barrett Universal II and Hill-RBF) is more precise for these challenging eyes.
- Conditions
- Refractive Errors, Cataract
- Being tested
- Phacoemulsification cataract surgery
- Keywords
- pseudoexfoliation, phacoemulsification cataract surgery, IOL power calculation formulas
- Medical subject headings
- Refractive Errors, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification cataract surgeryProcedure or surgery
All surgeries were performed using Infinity (Alcon Laboratories, Inc.) under topical anaesthesia by one surgeon through 2.2 mm incision in the upper corneal limbus. The hydroimplantation of IOL to the capsular bag was performed in all cases.
| Study group | Role | What they receive |
|---|---|---|
| PEX | 42 eyes with PEX syndrome and coexisting cataract Receives: Procedure: Phacoemulsification cataract surgery | |
| Control | 38 eyes with cataract only Receives: Procedure: Phacoemulsification cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare refractive outcomes in PEX and control eyes.
To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery
Measured: 3 months
Secondary outcomes (1)
To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.
To measure the effects of IOL power calculation formulas - SRK/T, Barrett Universal II and Hill-RBF - on postoperative refraction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Oct 2016
- Primary completion31 Dec 2017
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Żarnowski, MD, PhD, Professor, Study chair, Medical University in Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783909
- Sponsor's protocol ID
- KE-0254/241/2014
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wlaz A, Kustra A, Rozegnal-Madej A, Zarnowski T. Intraocular lens power calculations in eyes with pseudoexfoliation syndrome. Sci Rep. 2021 Sep 24;11(1):19071. doi: 10.1038/s41598-021-98675-5.
PubMed 34561548
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome
- ClinicalTrials.gov ID
- NCT04783909
- Acronym / sponsor ID
- KE-0254/241/2014
- Conditions
- Refractive Errors, Cataract
- Keywords
- pseudoexfoliation, phacoemulsification cataract surgery, IOL power calculation formulas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 5 Mar 2021 (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.
To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX.
Detailed description
The primary outcome measure was to compare refractive outcomes (MAE, MedAE, percentage of eyes within certain range of prediction error) in PEX and control eyes. The secondary outcome measure was to determine whether any of IOL power prediction formulas (SRK/T, Barrett Universal II and Hill-RBF) is more precise for these challenging eyes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEX | – | Procedure: Phacoemulsification cataract surgery42 eyes with PEX syndrome and coexisting cataract |
| Control | – | Procedure: Phacoemulsification cataract surgery38 eyes with cataract only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above 18 yo with senile cataract with/without PEX without coexisting ocular pathologies
Key inclusion criteria (1 listed)
- senile cataract with/without PEX
Key exclusion criteria (9 listed)
- corneal pathology
- glaucoma,
- corneal astigmatism greater than 2.0 diopters (D),
- previous eye surgery or subjects with decreased vision due to other reasons than cataract (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases),
- intraoperative complications,
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 |
|---|---|---|
| Phacoemulsification cataract surgeryAll surgeries were performed using Infinity (Alcon Laboratories, Inc.) under topical anaesthesia by one surgeon through 2.2 mm incision in the upper corneal limbus. The hydroimplantation of IOL to the capsular bag was performed in all cases. | Procedure or surgery | Control, PEX |
Primary outcome
To compare refractive outcomes in PEX and control eyes.
Time frame: 3 months
To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery
1 secondary outcome
To determine whether any of IOL power prediction formulas is more precise for these challenging eyes.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Derived from this study: PubMed 34561548Wlaz A, Kustra A, Rozegnal-Madej A, Zarnowski T. Intraocular lens power calculations in eyes with pseudoexfoliation syndrome. Sci Rep. 2021 Sep 24;11(1):19071. doi: 10.1038/s41598-021-98675-5.
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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.
Tomasz Żarnowski, MD, PhD, Professor study chair
Medical University in Lublin
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors and Cataract, run by Medical University of Lublin.
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 9 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare refractive outcomes in PEX and control eyes. (time frame: 3 months). 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 NCT04783909, which also lists 1 linked publication.
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 5 Mar 2021.