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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

Trial Contacts

ContactsICMJE

Dr Jahangir Alam

cataract-iol@bmu.ac.bd

Study Record Dates

First SubmittedICMJENot provided
First PostedICMJE

2026-05-27

Last Update Posted

2026-07-15

Last Verified*

2026-07

Outcome Measures

Primary Outcome Measures*ICMJE

Best-corrected visual acuity [Time Frame: 6 weeks]

Secondary Outcome Measures[*]ICMJE

Intraoperative complication rate [Time Frame: At surgery]

Other Pre-specified Outcome MeasuresNot provided

See all versions of this study

Trial Description

Brief Title*ICMJE

Cataract Surgery Outcomes With a Low-cost Intraocular Lens

Official Title*§ICMJE

Visual Outcomes and Complication Rates of a Low-cost Foldable Intraocular Lens in Routine Cataract Surgery

Acronym[*]Not provided
Brief Summary*

This trial evaluates visual outcomes and complication rates of a low-cost foldable intraocular lens in routine cataract surgery.

Detailed Description

Patients undergoing cataract surgery receive the low-cost intraocular lens. Best-corrected visual acuity is assessed at six weeks.

Study Type*ICMJE

Interventional

Study Phase*ICMJE

N/A

Study Design*§ICMJE

Allocation: N/A

Interventional Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Condition*ICMJE

Cataract

Keywords

cataract

intraocular lens

ophthalmology

Intervention*ICMJE

Device: Low-cost foldable intraocular lens

Procedure/Surgery: Phacoemulsification cataract surgery

Study Arms*ICMJE

Experimental: Low-cost IOL

Interventions: Device: Low-cost foldable intraocular lens; Procedure/Surgery: Phacoemulsification cataract surgery

PublicationsNot provided

Recruitment Information

Recruitment Status*ICMJE

Recruiting

Enrollment (Anticipated)*§ICMJE

480

Study Start Date*§ICMJE

2026-06-01

Primary Completion Date*

2027-02-28 (Final data collection date for primary outcome measure)

Study Completion Date*§ICMJE

2027-05-31

Eligibility Criteria*ICMJE

<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>

Sex/Gender*ICMJE

Sexes Eligible for Study: All

Ages*ICMJE

50 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers*§ICMJE

No

Location CountriesICMJE

Bangladesh

Administrative Information

BDCTR NumberICMJE

BDCTR-2026-000078

Other Study ID Numbers[*]ICMJE

BMU-OPH-2026-001

Has Data Monitoring Committee

No

Studies a U.S. FDA-regulated Drug ProductNot provided
Studies a U.S. FDA-regulated Device ProductNot provided
Device Product Not Approved or Cleared by U.S. FDANot provided
Pediatric Postmarket Surveillance of a Device ProductNot provided
Product Manufactured in and Exported from the U.S.Not provided
IPD Sharing StatementICMJE

Plan to Share IPD: Not provided

Current Responsible Party*

Dr Jahangir Alam

Current Study Sponsor*ICMJE

Bangladesh Medical University

CollaboratorsICMJENot provided
InvestigatorsICMJENot provided
Registry Account

Imported legacy public registry

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*§
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[*]
Conditionally required
No Symbol
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ICMJE
Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP