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Cataract Surgery Outcomes With a Low-cost Intraocular Lens

BDCTR ID
BDCTR-2026-000078
Sponsor
Bangladesh Medical University
Information provided by
Dr Jahangir Alam (Responsible Party)
Last Update Posted
2026-07-15

Recruiting

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Study Record Versions

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12026-07-15Current
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Viewing V1 (2026-07-15)

Study Details

Study Identification

Unique Protocol IDBMU-OPH-2026-001
Brief TitleCataract Surgery Outcomes With a Low-cost Intraocular Lens
Official TitleVisual Outcomes and Complication Rates of a Low-cost Foldable Intraocular Lens in Routine Cataract Surgery
Secondary IDs

Study Status

Record Verification2026-07
Overall StatusRecruiting
Study Start2026-06-01
Primary Completion2027-02-28
Study Completion2027-05-31
First Submitted
First Submitted that Met QC Criteria2026-05-27
First Posted2026-05-27 [Actual]
Last Update Submitted that Met QC Criteria2026-07-15
Last Update Posted2026-07-15 [Actual]

Oversight

U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Product manufactured in and exported from the U.S.
Data MonitoringNo

Study Description

Brief SummaryThis trial evaluates visual outcomes and complication rates of a low-cost foldable intraocular lens in routine cataract surgery.
Detailed DescriptionPatients undergoing cataract surgery receive the low-cost intraocular lens. Best-corrected visual acuity is assessed at six weeks.

Conditions

ConditionCataract
Keywordscataract intraocular lens ophthalmology

Study Design

Study TypeInterventional
Primary PurposeTreatment
Study PhaseN/A
Interventional Study ModelSingle Group Assignment
Number of Arms1
MaskingNone (Open Label)
AllocationN/A
Enrollment480 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
Experimental: Low-cost IOLDevice: Low-cost foldable intraocular lens Procedure/Surgery: Phacoemulsification cataract surgery

Outcome Measures

Primary Outcome MeasuresBest-corrected visual acuity Time Frame: 6 weeks
Secondary Outcome MeasuresIntraoperative complication rate Time Frame: At surgery

Eligibility

Minimum Age50 Years
Maximum Age
Ages50 Years and older (Adult, Older Adult)
SexAll
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersNo
Criteria<p>Inclusion Criteria:</p><ul><li>Adults aged 50 years and older with visually significant cataract.</li></ul><p>Exclusion Criteria:</p><ul><li>Prior intraocular surgery in the study eye.</li></ul>

Contacts/Locations

Central Contact PersonDr Jahangir Alam cataract-iol@bmu.ac.bd
Study Officials
LocationDhaka, Dhaka, Bangladesh, 1000 Status: Recruiting Facility: Bangladesh Medical University, Department of Ophthalmology

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents