NCT07605026

Brief Summary

This study aims to compare the outcomes of endoscopic DCR performed with versus without internal nasal splints, by assessing functional outcomes, complication rates, and overall success rates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Synechia After DCR

Outcome Measures

Primary Outcomes (1)

  • Success rates as Stomal patency , absence of formation of synechia and cessation of epiphora.

    Evaluation will be done by nasal endoscopic examination of the middle meatus after 1 month

Study Arms (2)

Endoscopic DCR with internal nasal splint

ACTIVE COMPARATOR

Patients will undergo Endoscopic DCR with putting internal nasal splint between middle turbinate and middle meatus

Procedure: Endoscopic DCR with putting internal nasal splint

Endoscopic DCR without internal nasal splint.

ACTIVE COMPARATOR

Patients will undergo Endoscopic DCR without putting internal nasal splint between middle turbinate and middle meatus

Procedure: Endoscopic DCR without putting internal nasal splint

Interventions

Endoscopic DCR with putting internal nasal splintPROCEDURE

Patients will undergo Endoscopic DCR with putting internal nasal splint between middle turbinate and middle meatus

Endoscopic DCR with internal nasal splint
Endoscopic DCR without putting internal nasal splintPROCEDURE

Patients will undergo Endoscopic DCR without putting internal nasal splint between middle turbinate and middle meatus

Endoscopic DCR without internal nasal splint.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years. Symptomatic NLDO (epiphora, recurrent dacryocystitis). Fit for general anesthesia

You may not qualify if:

  • Congenital dacryocystitis. Canalicular or punctal obstruction. Previous lacrimal surgery. Post-traumatic or post-radiation epiphora. Coexisting nasal pathology (tumors, granulomatous disease, atrophic rhinitis). Immunocompromised or uncontrolled systemic disease. Patients unwilling to undergo endoscopic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University Hospitals

Kafrelsheikh, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

January 15, 2024

Primary Completion

June 5, 2025

Study Completion

July 3, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

EG(1)