UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053664 |
|---|---|
| Receipt number | R000061247 |
| Scientific Title | Surgical outcome of modified double-needle flanged intraocular lens intrascleral fixation |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2026/08/06 19:37:48 |
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Basic information
Public title
Surgical outcome of modified double-needle flanged intraocular lens intrascleral fixation
Acronym
Surgical outcome of modified double-needle flanged intraocular lens intrascleral fixation
Scientific Title
Surgical outcome of modified double-needle flanged intraocular lens intrascleral fixation
Scientific Title:Acronym
Surgical outcome of modified double-needle flanged intraocular lens intrascleral fixation
Region
| Japan |
Condition
Condition
Intraocular lens (sub)dislocation, lens (sub)dislocation, aphakic eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate surgical outcome of modified double-needle flanged intraocular lens intrascleral fixation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular lens fixation position, visual acuity, refraction
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Corneal endothelial cell density greater than 1500/mm2
Intraocular lens (sub)dislocation, lens (sub)dislocation, aphakia
Key exclusion criteria
Presence of filtration bleb, significant surgical scarring
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennnojiku, Osaka
TEL
81-6-6774-5111
masayuki@akimoto3.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akimoto |
Organization
Osaka Red Cross Hospital
Division name
Ophthalmology
Zip code
543-8555
Address
5-30 Fudegasakicho, Tennnojiku, Osaka
TEL
81-6-6774-5111
Homepage URL
masayuki@akimoto3.com
Sponsor or person
Institute
Osaka Red Cross Hospital
Institute
Department
Personal name
Masayuki
Funding Source
Organization
Osaka Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Not required for this country
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Red Cross Hospital Medical Ethics Review Committee
Address
5-30 Fudegasakicho, Tennojiku, Osaka
Tel
+81667745111
soumudaiichi@osaka-med.jrc.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
20
Results
The mean BCVA significantly improved from 0.46 +/- 0.66 logMAR to 0.11 +/- 0.38 logMAR. The mean ECD decreased from 2301 +/- 332 cells/mm to 2074 +/- 507 cells/mm. The mean IOL tilt was 5.77 +/- 2.78 degrees.
Results date posted
| 2026 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Parameters
Values / Percentages
Eyes (n)
21
Age (years, mean +/- SD)
70.0 +/- 15.3
Male sex (n [%])
18 (86%)
Diagnosis (n [%])
Aphakia
0 (0%)
IOL dislocation
14 (67%)
Lens dislocation
7 (33%)
Axial Length (AL) (mm)
25.45 +/- 1.73
Refractive errors (spherical equivalent, diopters)
0.65 +/- 5.1
Intraocular Pressure (IOP) (mmHg)
17.4 +/- 4.2
Baseline logMAR BCVA
0.46 +/- 0.66
logMAR BCVA at 1 month
0.11 +/- 0.38
Baseline Corneal endothelial cell density (cells/mm)
2301 +/- 332
Participant flow
1. Screening
Recruitment Pool: Patients who underwent intrascleral IOL fixation with 27-gauge needles at Osaka Red Cross Hospital between March and September 2024.
Inclusion Criteria: Patients meeting the criteria of having aphakia, a dislocated IOL, or a subluxated crystalline lens, who provided informed consent.
Exclusion Criteria: Patients were excluded if they had active retinal diseases (like retinal detachment or macular pucker), high preoperative intraocular pressure (IOP > 25 mmHg), scleritis, were under 20 years old, or had a postoperative follow-up of less than 1 month.
2. Enrollment & Intervention
Total Enrolled: 21 eyes of 20 patients successfully met the criteria and underwent the zigzag-needle flangeless intrascleral IOL fixation procedure.
Breakdown of Treated Patients:
14 eyes (67%): Treated for IOL dislocation.
7 eyes (33%): Treated for lens dislocation/subluxation.
3. Follow-up & Analysis
Completed Follow-up: All 21 eyes completed the 1-month postoperative follow-up.
Adverse events
Postoperative complications included vitreous hemorrhage in 1 eye (4.8%), temporary IOP elevation in 1 eye (4.8%), transient corneal edema in 1 eye (4.8%), and 1 case of intraoperative rhegmatogenous retinal detachment (4.8%; Table 2). The vitreous hemorrhage disappeared within 2 weeks of surgery. Iris capture of the IOL was not observed in any patient, and repositioning of the IOL for IOL tilt was performed in 1 patient (4.8%).
Outcome measures
Parameters
Values / Percentages
logMAR BCVA at 1 month
0.11+/- 0.38
Baseline Corneal endothelial cell density (cells/mm)
2301 +/- 332
Corneal endothelial cell density at 1 month (cells/mm)
2074 +/- 507
Intraocular Lens Power (D)
17.7 +/- 3.8
Refractive difference (diopters)
-0.33 +/- 0.83
Intraocular Lens Tilt
5.77 +/- 2.78
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Double-needle intraocular lens intrascleral fixation has room for certain improvements.
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061247
