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Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

M

Minia University

Status

Enrolling

Conditions

Acquired Nasolacrimal Duct Obstruction

Treatments

Other: DCR

Study type

Interventional

Funder types

Other

Identifiers

NCT06530264
Posterior flap managing in DCR

Details and patient eligibility

About

The aim of DCR is to form a new, mucosa-lined pathway between the lacrimal sac and the nasal cavity where tears can bypass a lacrimal obstruction and drain directly in the nose. The original external approach was described in 19046. In 1920s, mucosal flap anastomosis was added to the procedure as a modification7, and since then, many new modifications have been made to improve the original procedure.

Full description

Aim of The Study

• To compare intraoperative details and postoperative endonasal endoscopic findings and their effects on success rate of external dacryocystorhinostomy with and without anastomosis of posterior mucosal flaps.

Patients and Methods

Study Design: This will be a prospective interventional comparative clinical study. It will include two groups according to the surgical procedure:- Group A: includes 30 eyes that will be treated with external DCR with anastomosis of posterior mucosal flaps .

Group B: includes 30 eyes that will be treated with external DCR with amputation of posterior mucosal flaps .

Study Population:

Study participants will be: 60 eyes undergo external DCR . All patients included in this study will be verbally briefed about the details and the nature of the study & will sign a written consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Ophthalmology department, Minia university Hospital, Egypt.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Patients with chronic dacryocystits,
  • primary nasolacrimal duct obstruction
  • Lacrimal mucocele
  • Lacrimal fistula

Exclusion Criteria:

  • Recurrent cases.
  • Age under 5 years.
  • Associated nasal pathology.
  • Sever dry eye
  • Patients unfit for general anaesthesia

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 1 patient group

External DCR
Other group
Description:
Different techniques in posterior flap management
Treatment:
Other: DCR

Trial contacts and locations

1

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Central trial contact

Mohamed Farouk Sayed, Prof; Mohammed Sayed Abdelmaaboud, MD

Data sourced from clinicaltrials.gov

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