UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045158 |
|---|---|
| Receipt number | R000050642 |
| Scientific Title | Postoperative intraocular lens position in phaco-vitrectomy and phacoemulsification alone. |
| Date of disclosure of the study information | 2021/08/15 |
| Last modified on | 2026/02/23 10:02:32 |
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Basic information
Public title
Postoperative intraocular lens position in phaco-vitrectomy and phacoemulsification alone.
Acronym
Postoperative intraocular lens position
Scientific Title
Postoperative intraocular lens position in phaco-vitrectomy and phacoemulsification alone.
Scientific Title:Acronym
Postoperative intraocular lens position
Region
| Japan |
Condition
Condition
Cataract
Epiretinal/Epimacular membrane
Macular hole
Vitreomacular traction syndrome
Vitreous hemorrhage
Retinal detachment
Diabetic macular retinopathy
Central/Branch retinal vein occlusion
Subretinal hemorrhage
Vitreous opacity
Classification by specialty
| Hepato-biliary-pancreatic medicine | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the intraocular lens position and refractive error after surgery in three groups (phacoemulification alone, phacovitrectomy without gas tamponade, and phacovitrectomy with gas tamponade) depending on the intraocular lens type.
Basic objectives2
Others
Basic objectives -Others
To evaluate the postoperative refractive error by surgical method and intraocular lens type.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The position of intraocular lenses at 6 month post-operation.
Key secondary outcomes
Lens position at 1 and 3 m postoperatively
Comparison of postoperative refractive error by IOLs
Comparison of postoperative refractive error by surgical procedure
Comparison of postoperative refractive error by type of gas tamponade
Comparison of postoperative refractive error by IOL power determination formula
Higher order aberrations (tilt/deviation) by IOL type
Comparison by disease
Comparison of the shape of the IOL optical cover by anterior capsule
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1-piece acrylic lens (Clareon, Alcon co.)
Interventions/Control_2
3-piece acrylic lens (Avansee, Kowa co.)
Interventions/Control_3
3-piece larger optical diameter acrylic lens
((N)X-70, Santen co.)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have the following diseases and who need phacoemulification or phacovitrectomy with intraocular lens implantation.
1. Cataract
2. Epiretinal/Epimacular membrane
3. Macular hole
4. Vitreomacular traction syndrome
5. Vitreous hemorrhage
6. Retinal detachment
7. Diabetic macular retinopathy
8. Central/Branch retinal vein occlusion
9. Subretinal hemorrhage
10. Vitreous opacity
Key exclusion criteria
1. Patients with difficulty to be implanted intraocular lens fixation in the bag
2. Patients who implant an intraocular lens different from those used in this study.
3. Patients who hope to be implanted the specific intraocular lens.
4. Patients who should be implanted the specific intraocular lens.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Tatsushi |
| Middle name | |
| Last name | Kaga |
Organization
Japan Community Healthcare Organization Chukyo Hospital
Division name
Ophthalmology
Zip code
4578510
Address
1-1-10 Sanjo, Minami-ku, Nagoya, Aichi
TEL
052-691-7151
kaga@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Yokoyama |
Organization
Japan Community Healthcare Organization Chukyo Hospital
Division name
Ophthalmology
Zip code
4578510
Address
1-1-10 Sanjo, Minami-ku, Nagoya, Aichi
TEL
052-691-7151
Homepage URL
yokoyama@chukyogroup.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Chukyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization Chukyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Healthcare Organization Chukyo Hospital Institutional Review Board
Address
1-1-10 Sanjo, Minami-ku, Nagoya, Aichi
Tel
052-691-7151
rinrikanri@chukyo.jcho.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020053
Org. issuing International ID_1
Japan Community Healthcare Organization Chukyo Hospital Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
86
Results
Group A: Combined cataract and vitrectomy without gas (41 eyes). No significant differences in postoperative anterior chamber depth (ACD) or refractive error were observed among IOL types.
Group B: Combined cataract and vitrectomy with gas (49 eyes). The 3-piece 6.0-mm IOL showed smaller ACD at 1 month vs the 1-piece 6.0-mm IOL (P=0.0377) and tended to have smaller ACD at other time points. Refractive error did not differ significantly, although the 3-piece 6.0-mm IOL tended to show larger errors.
Results date posted
| 2026 | Year | 02 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with the following target conditions who were determined to require cataract surgery or combined cataract and vitrectomy surgery between the start of the study and December 31, 2023, and for whom in-the-bag intraocular lens (IOL) implantation was planned were eligible for inclusion.
Participant flow
In addition to routine preoperative examinations, two types of axial length measurements (ARGOS and IOLMaster) and anterior segment optical coherence tomography (CASIA2) will be performed. Axial length measurement is mandatory as part of standard preoperative assessment in routine clinical practice.
Postoperative evaluations will be conducted immediately after surgery (on postoperative day 0-3), and at 1, 3, and 6 months postoperatively. In addition to routine examinations, two types of axial length measurements (ARGOS and IOLMaster), anterior segment OCT (CASIA2), and ocular aberration measurements (OPD-Scan III) will be performed.
All ophthalmic examinations conducted before and after surgery are noninvasive and painless. There will be no additional financial burden to the participants. Each examination session will require approximately 10-20 minutes.
Adverse events
None
Outcome measures
Anterior chamber depth (ACD) was measured using CASIA2 (Tomey, Nagoya, Japan), and postoperative refractive error was evaluated. These parameters were compared among different intraocular lens (IOL) types preoperatively, immediately after surgery (postoperative days 0-3), and at 1, 3, and 6 months postoperatively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 15 | Day |
Last modified on
| 2026 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050642
