CAPSULaser in Cases of Intumescent Cataract | NCT07266844

Studies
CAPSULaser in Cases of Intumescent Cataract

NCT07266844

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Dec 5, 2025Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Intumescent Cataract

Interventions

CAPSULaser
capsulotomy

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Maghrabi eye hospitals	Other Identifier	Maghrabi eye hospitals

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2025Actual

Primary Completion Date

Nov 6, 2025Actual

Completion Date

Nov 6, 2025Actual

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Dec 4, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

evaluating the use of selective laser in doing capsulotomy in intumescent cataract

Detailed Description

Evaluating the safety and advantages of using selective laser capsulotomy for capsulorhexis creation in intumescent cataract

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intumescent cataract	Other	CAPSULaser	Procedure: CAPSULaser Device: capsulotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAPSULaser	Procedure	doing capsulotomy using CAPSULaser	intumescent cataract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure the actual size compared to result size as measured by slit lamp in mm	To measure the actual size compared to result size as measured by slit lamp	3 months
Incidence and number of extended capsulorhexis to the total number of cases	Incidence and number of extended capsulorhexis	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with intumescent cataract and good pupil dilatation

Exclusion Criteria:

absence of corneal scaring

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Magrabi eye hospitals		Jeddah	Jedda	22233	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064727	Posterior Capsulotomy

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided