Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02993770
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2016-09-10
Brief Title:
Endo-nasal Endoscopic DCR and External-DCR in Primary Nasolacrimal Duct Obstruction
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Comparison of Endonasal-Endoscopic Dacryocystorhinostomy Versus External Dacryocystorhinostomy
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All patients with epiphora or eye discharge that admitted to our ophthalmic plastic clinic in Farabi hospital will be systemically evaluated Those with confirmed diagnosis of primary nasolacrimal duct obstruction PANDO that need DCR by one senior ophthalmic plastic consultant will be randomly assigned to one of the 2 treatment groups Group 1 External DCR and group 2 En-DCR Diagnosis of PANDO will be based on the presence of positive regurgitation test or irrigation test or dacryocystography DCG All patients will undergo comprehensive ophthalmology examinations including best corrected visual acuity BCVA relative afferent pupillary defect RAPD slit lamp anterior segment evaluation dilated fundoscopy with 78 D lens Past history and review os systems will be elicited for medications past or intercurrent dacryocystitistraumapast ocular and sinus surgeries epiphora discharge ocular diseases sinusnasal diseases diabetes mellitus organ transplant immunosuppressive drugs and immunodeficiency disorders
All operations will be performed under general or local anesthesia based on patient and surgeon preferences
Surgical Technique
All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in endoscopic surgery FP with a modified powered endonasal endoscopic technique described by Wormold
Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal sac will be incised and elevated Then rhinostomy will be made using forceps exposing lacrimal sac Lacrimal sac will be opened and a Crawford silicone tube will be passed through puncta into nasal cavity and stabilized and will be kept for 2 months After operation patients will receive nasal beclomethasone twice daily for 2 weeks nasal drop phenylephrine 025 four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily for one week
External DCR will be performed in a conventional manner 2via a nasal side straight skin incision 1 cm medial to medial canthal area 1 cm long then orbicularis oculi muscle will be separated using blunt dissection to expose the periosteum overlying and medial to the anterior lacrimal crest After incision of the periosteum an osteotomy approximately 10 mm in diameter will be prepared The lacrimal sac and then nasal mucosa will be opened by an H incision to form maximal anterior flaps A Bodkin tube will be passed through puncta into nasal cavity of stabilized by multiple square knots at the end The small posterior flaps will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl sutures The periosteum orbicularis oculi muscle will be sutured by 6-0 vicryl sutures Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner Nasal packing will not be placed All Ext-DCR operations will be performed by one of the two expert ophthalmic plastic surgeons FP and AK
The amount of bleeding will be estimated and recorded by the subtracting the total suction reservoir from the amount of irrigated fluid through syringe during operation Time of operation will be estimated and recorded from the time of anesthetics injection to removing the drape
One week after operation patients will be asked to report post-operative pain and discomfort by visual analogue score scale 0-10
27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is healed and complications if any will be detected and recorded in the special data sheets Nasal bleeding medial canthal swelling and erythema ocular surface fluorescein staining and any complications will be detected and recorded Dye disappearance test DDT will be checked and recorded Epiphora will be recorded according to modified Munk epiphora staging scale
Two months after operation ocular surface will be checked by fluorescein for staining of cornea and conjunctiva Then silicone tube will be removed epiphora will be recorded according to our staging system Dye disappearance test DDT and Fluorescein Dynamic Dye test FDDT and irrigation test epiphora and skin scar by visual analogue scale VAS visual analogue scale will be checked in months 2 6 12 18 and after operation Satisfaction will be checked 2 mo and 18 mo after operation by VAS Any grade of daily epiphora or return of fluid20 through opposite punctum in irrigation test or negative FDDT absence of fluid passage will be regarded as functional or anatomic failure respectively Any complication will be recorded in the specific forms
All pre-operative and post-op examinations will be performed by a masked senior ophthalmology resident subjective data will be checked and recorded by a trained nurse
All operations will be performed under general or local anesthesia based on patient and surgeon preferences
Surgical Technique
All En-DCR surgeries will be performed by a single ophthalmic plastic surgeon expert in endoscopic surgery FP with a modified powered endonasal endoscopic technique described by Wormold
Using a 0 degree 4-mm endonasal endoscope nasal mucoperiosteum in the area of the lacrimal sac will be incised and elevated Then rhinostomy will be made using forceps exposing lacrimal sac Lacrimal sac will be opened and a Crawford silicone tube will be passed through puncta into nasal cavity and stabilized and will be kept for 2 months After operation patients will receive nasal beclomethasone twice daily for 2 weeks nasal drop phenylephrine 025 four times daily and ophthalmic drop fluorometholone and Levofloxacin four times daily for one week
External DCR will be performed in a conventional manner 2via a nasal side straight skin incision 1 cm medial to medial canthal area 1 cm long then orbicularis oculi muscle will be separated using blunt dissection to expose the periosteum overlying and medial to the anterior lacrimal crest After incision of the periosteum an osteotomy approximately 10 mm in diameter will be prepared The lacrimal sac and then nasal mucosa will be opened by an H incision to form maximal anterior flaps A Bodkin tube will be passed through puncta into nasal cavity of stabilized by multiple square knots at the end The small posterior flaps will be cut and excised and anterior flaps will be sutured together with 2 or 3 6-0 vicryl sutures The periosteum orbicularis oculi muscle will be sutured by 6-0 vicryl sutures Skin will be sutured by Nylon 6-0 by interrupted style in the standard manner Nasal packing will not be placed All Ext-DCR operations will be performed by one of the two expert ophthalmic plastic surgeons FP and AK
The amount of bleeding will be estimated and recorded by the subtracting the total suction reservoir from the amount of irrigated fluid through syringe during operation Time of operation will be estimated and recorded from the time of anesthetics injection to removing the drape
One week after operation patients will be asked to report post-operative pain and discomfort by visual analogue score scale 0-10
27 Seven days after operation skin sutures of patients in group 2 will be removed if skin is healed and complications if any will be detected and recorded in the special data sheets Nasal bleeding medial canthal swelling and erythema ocular surface fluorescein staining and any complications will be detected and recorded Dye disappearance test DDT will be checked and recorded Epiphora will be recorded according to modified Munk epiphora staging scale
Two months after operation ocular surface will be checked by fluorescein for staining of cornea and conjunctiva Then silicone tube will be removed epiphora will be recorded according to our staging system Dye disappearance test DDT and Fluorescein Dynamic Dye test FDDT and irrigation test epiphora and skin scar by visual analogue scale VAS visual analogue scale will be checked in months 2 6 12 18 and after operation Satisfaction will be checked 2 mo and 18 mo after operation by VAS Any grade of daily epiphora or return of fluid20 through opposite punctum in irrigation test or negative FDDT absence of fluid passage will be regarded as functional or anatomic failure respectively Any complication will be recorded in the specific forms
All pre-operative and post-op examinations will be performed by a masked senior ophthalmology resident subjective data will be checked and recorded by a trained nurse
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None