UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058043 |
|---|---|
| Receipt number | R000066345 |
| Scientific Title | Outcomes and surgically induced astigmatism in manual small incision cataract surgery: a randomized clinical trial comparing various scleral incision techniques. |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/06/02 07:49:57 |
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Basic information
Public title
Scleral Incision Shapes and Visual Outcomes in MSICS"
Acronym
SISVOM
Scientific Title
Outcomes and surgically induced astigmatism in manual small incision cataract surgery: a randomized clinical trial comparing various scleral incision techniques.
Scientific Title:Acronym
OSIAMSICS
Region
| Africa |
Condition
Condition
Cataract surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate and compare the impact of different scleral incision types straight, frown, and chevron on visual outcomes and surgically induced astigmatism (SIA) in patients undergoing manual small incision cataract surgery (MSICS). By analyzing the postoperative visual acuity and changes in corneal curvature, the study aims to determine which incision geometry offers the most favorable outcomes in terms of minimizing astigmatism and optimizing visual recovery. This is particularly relevant for resource limited settings where access to postoperative refractive correction is often restricted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
"1- Surgically Induced Astigmatism (SIA):
- Quantified by the difference in keratometric values pre- and postoperatively.
- Compared across the three incision types (straight, frown, chevron).
2- Postoperative Visual Acuity:
- Uncorrected Visual Acuity (UCVA) and Best-Corrected Visual Acuity (BCVA) at 30 days post-surgery.
- Used to assess functional visual recovery."
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Straight Incision Arm: Patients receive MSICS with a straight scleral incision.
Interventions/Control_2
Frown Incision Arm: Patients receive MSICS with a frown-shaped scleral incision.
Interventions/Control_3
Chevron Incision Arm: Patients receive MSICS with a chevron (inverted V-shaped) scleral incision.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 40 to 80 years.
Diagnosed with age-related cataract.
Scheduled for manual small incision cataract surgery (MSICS).
Preoperative visual acuity < 1/10 (Snellen equivalent).
Provided written informed consent.
Surgery performed at CHU-IOTA, Bamako, Mali under a standardized protocol.
Key exclusion criteria
Pre-existing corneal abnormalities.
Irregular astigmatism.
History of ocular surgery in the operated eye.
Any condition that would interfere with accurate keratometric or visual assessment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Nouhoum |
| Middle name | |
| Last name | Guirou |
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Division name
Ophthalmology/Oculoplastics
Zip code
91093
Address
Boulevard du Peuple Centre commercial Bamako/Mali
TEL
+22366809004
guiroun@gmail.com
Public contact
Name of contact person
| 1st name | Nouhoum |
| Middle name | |
| Last name | Guirou |
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Division name
Ophthalmology/Oculoplastics
Zip code
91093
Address
Boulevard du Peuple Centre commercial Bamako/Mali
TEL
+22366809004
Homepage URL
guiroun@gmail.com
Sponsor or person
Institute
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Institute
Department
Personal name
Funding Source
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Address
Boulevard du Peuple Centre commercial Bamako/Mali
Tel
+22366809004
guiroun@gmail.com
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
| 2025 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066345
