Cataract SenileNCT06165796
The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study
An observational study of Cataract Senile, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
Trial summary
Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as difference between postoperative sphere and… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- routine cataract surgery and intraocular lens implantation
- Type of treatment
- Medical device
- How many people
- 331 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 1 Dec 2023
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clear corneal phacoemulsification and IOL implantation were performed by single surgeon Chao-Kai Chang. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include only EDOF Symfony IOL (Johnson and Johnson, Santa Ana, CA, USA).
Who may be able to join
- presence of cataract in both eyes
- corrected distance visual acuity under 20/40
- Phacoemulsification cataract surgery was arranged for both eyes
Who cannot join
- complicated cataract
- corneal opacities or irregularities
- corneal astigmatism > 1.50 diopter
- amblyopia, anisometropia
- surgical complications such as posterior capsular bag rupture or vitreous loss, IOL tilt or decentration
- coexisting ocular pathologies, glaucoma, non-dilating pupil, history of intraocular surgery, or retinopathy
- optic nerve or macular diseases
- refusal or unable to maintain follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as difference between postoperative sphere and target refraction.
- Conditions
- Cataract Senile
- Being tested
- routine cataract surgery and intraocular lens implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine cataract surgery and intraocular lens implantationDevice
routine cataract surgery and intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| previous LASIK group | Not described Receives: Device: routine cataract surgery and intraocular lens implantation | |
| previous non-LASIK group | Not described Receives: Device: routine cataract surgery and intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Measured: 1 month after surgery
refractive prediction error
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2022
- Primary completion30 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cataract SenileStudies 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
- Retrospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Nobel Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Kai Chang, Taipei Nobel Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165796
- Sponsor's protocol ID
- 004
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19.
PubMed 27006324Yeu E, Cuozzo S. Matching the Patient to the Intraocular Lens: Preoperative Considerations to Optimize Surgical Outcomes. Ophthalmology. 2021 Nov;128(11):e132-e141. doi: 10.1016/j.ophtha.2020.08.025. Epub 2020 Aug 31.
PubMed 32882308
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study
- ClinicalTrials.gov ID
- NCT06165796
- Acronym / sponsor ID
- 004
- Conditions
- Cataract Senile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Taipei Nobel Eye ClinicUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Dec 2023 (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.
Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as difference between postoperative sphere and target refraction.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| previous LASIK group | – | Device: routine cataract surgery and intraocular lens implantation |
| previous non-LASIK group | – | Device: routine cataract surgery and intraocular lens implantation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clear corneal phacoemulsification and IOL implantation were performed by single surgeon Chao-Kai Chang. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include only EDOF Symfony IOL (Johnson and Johnson, Santa Ana, CA, USA).
Key inclusion criteria (3 listed)
- presence of cataract in both eyes
- corrected distance visual acuity under 20/40
- Phacoemulsification cataract surgery was arranged for both eyes
Key exclusion criteria (8 listed)
- complicated cataract
- corneal opacities or irregularities
- corneal astigmatism > 1.50 diopter
- amblyopia, anisometropia
- surgical complications such as posterior capsular bag rupture or vitreous loss, IOL tilt or decentration
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 |
|---|---|---|
| routine cataract surgery and intraocular lens implantationroutine cataract surgery and intraocular lens implantation | Device | previous LASIK group, previous non-LASIK group |
Primary outcome
visual acuity
Time frame: 1 month after surgery
refractive prediction error
Time frame: 1 month after surgery
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 11 Dec 2023.
- Background: PubMed 27006324Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19.
- Results publication: PubMed 32882308Yeu E, Cuozzo S. Matching the Patient to the Intraocular Lens: Preoperative Considerations to Optimize Surgical Outcomes. Ophthalmology. 2021 Nov;128(11):e132-e141. doi: 10.1016/j.ophtha.2020.08.025. Epub 2020 Aug 31.
- Individual participant dataSharing planned: No
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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?
An observational study of Cataract Senile, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
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 3 inclusion and 8 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 11 Dec 2023. 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 Taiwan. 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 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?
visual acuity (time frame: 1 month after surgery). The study lists 2 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 NCT06165796, which also lists 2 linked publications.
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 11 Dec 2023.