AIM AND OBJECTIVES

·       To compare the anatomical and physiological success rates for early endonasal, delayed endonasal, and delayed external DCR surgery for AD cases

·       To assess the socioeconomic impact of treatment in terms of number of missed days at work, and total cost incurred during treatment for the AD patients

·       To assess the effectiveness of time-guided DCR interventions based on duration for subjective symptomatic relief

MATERIALS AND METHODS

STUDY DESIGN : Randomised control study

PLACE OF STUDY: Tejas eye Hospital (OPD and Oculoplasty clinic)

STUDY DURATION: 18 months

SAMPLE SIZE:

1.     The study by Wu et al.⁴ comparing the efficacy of early endonasal DCR vs delayed external DCR in cases of acute dacryocystitis was taken as a reference study. Success of 90 % (36/40) was reported in endonasal DCR group, and 65.6 % (21/32) in the delayed external DCR group. Assuming the study with two independent arms with a dichotomous primary outcome, power of 80% and 95% level of significance, Sample size is calculated as 44 in each group.

2.     Early endonasal DCR was compared with delayed endonasal DCR by Li et al.¹¹ for acute dacryocystitis. They noted a similar success rate of 87.5% in both groups. These groups could not be used for sample size calculation due to similar success rates.

Considering drop out and cases lost to follow-up, 15% additional cases will be taken for each group.

A sample size of 50 eyes will be required in each arm, considering 1 operated eye per patient.

STUDY POPULATION: At least 150 patients meeting the inclusion and exclusion criteria will be included in the study after taking a full written and informed consent. The patients will be randomized into three groups:

Group A (Early Endonasal group) – Patients will undergo endonasal DCR surgery, within 7 days of presentation at the centre

Group B (Delayed Endonasal group) - Patients will be medically managed for 3 weeks from day of presentation, followed by endonasal DCR surgery

Group C (External group) – Patients will be medically managed for 3 weeks from day of presentation, followed by external DCR surgery

RANDOMIZATION:

Block randomization will be done for the three blocks in ratio of 1:1:1. Computer generated random numbers of 0 (representing group A), 1 (representing group B), and 2 (representing group C) will be printed and placed in sequentially numbered, sealed, opaque envelopes in a box, under the supervision of a clerical staff. After consent from the participant, the assessing and operating surgeon will retrieve the randomization code and offer the surgical option accordingly.

INCLUSION CRITERIA: All patients with -

1.     Age between 18 – 50 years at enrolment

2.     Acute or subacute (<7 days) dacryocystitis at presentation

3.     Roomy ipsilateral nasal cavity

EXCLUSION CRITERIA

All known cases of -

1.            Coronary Artery Disease or cerebro-vascular disease patients on on anti-coagulation therapy, and patients of Bleeding disorders or coagulopathy

2.            Ongoing Pregnancy or planning a pregnancy during follow-up period

3.            Hypertension

4.            Nasal pathologies like atrophic rhinitis, nasal polyps, turbinate hypertrophy, deviated nasal septum etc

5.            Concurrent active upper respiratory tract infection, sinusitis, or orbital cellulitis

6.            Prior failed external DCR or endonasal DCR

7.            Concurrent punctal stenosis, proximal or distal canalicular block

8.            Past history of nasal trauma, mucormycosis, nasal malignancies, or past endoscopic endonasal surgeries for nasal pathologies

PRETREATMENT EVALUATION

HISTORY:

·       A detailed history regarding onset and progression of acute dacryocystitis will be taken.

·       Duration (in days) of epiphora, medial canthal swelling, and pain will be noted.

·       Any past history suggestive of previous surgeries will be noted.

·       Epiphora will be staged according to Munk score: 0 – No epiphora, 1 – dabbing <2 times a day, 2 – dabbing 2-5 times a day, 3 – dabbing 5-10 times a day, 4 – dabbing >5 times a day, 5 – constant epiphora.

·       Pain will be graded using visual analog scale (Likert) from 1 - 10.

·       The socio-economic status of the patient will be assessed using modified Kuppuswamy system.

·       The number of missed days of work and number of days with productivity < 50%, will be enquired.  

GENERAL PHYSICAL EXAMINATION – Temperature monitoring and Blood pressure(Systolic BP/Diastolic BP) will be regularly monitored.

OPHTHALMOLOGICAL EXAMINATION:

1.            BCVA (Best corrected Visual Acuity), Colour vision using Ishihara pseudoisochromatic plates, and Contrast sensitivity using Peli-Robson charts

2.            Pupil examination, fundus and optic nerve head examination

3.            Assessment of extraocular movements

4.            Assessment of proptosis, conjunctival congestion, and chemosis

5.            Evaluation of local inflammatory signs at medial canthus, Regurgitation on pressure over lacrimal sac area (ROPLAS) test, and presence of fistula

6.            Anterior rhinoscopy to assess adequacy of nasal cavity, deviation of nasal septum and any other nasal pathologies

7.            Photographic records at enrolment and on morning of surgery

SYSTEMIC Examination –

-     Respiratory System

-     Cardiovascular system

-     Central Nervous system

-     Gastro-intestinal system

INVESTIGATIONS:

Blood Investigations: Plasma glucose levels, Complete blood count with Erythrocyte Sedimentation Rate, Prothrombin time

SURGERY:

Endonasal DCR:

The surgery will be performed under local anaesthesia, with patient lying in supine position, with head high and chin up position. Lignocaine 2% with adrenaline 1:200000 will be used for local infiltration. The mucosal incision will be made above the axilla of middle turbinate, extended 10 mm anteriorly, down upto the origin of the inferior turbinate, and then continued posteriorly. The nasal mucosa will be reflected medially using suction and Freers’ elevator. The lacrimal bone and frontal process of maxilla will be identified and removed using Ronguer bone punch to expose the lacrimal sac completely. The probe will be passed from upper punctum to tent the medial wall of lacrimal sac and the sac will be opened along its length using sharp sickle knife. The sac incision will be extended to fashion anterior and posterior flaps. Syringing will be done to confirm free flow. Silicone bicanalicular intubation tube will be passed and tied in the nasal cavity. The sac flaps will be meticulously apposed to nasal mucosal flaps and nasal cavity will be packed with Adrenaline 1:200000 soaked nasal pack for 24 hours.

External DCR:

The surgery will be performed under local anaesthesia, with patient lying in supine position, with head high and chin up position. Lignocaine 2% with adrenaline 1:200000 will be used for local infiltration along infraorbital, infratrochlear, and dorsal nasal nerves. J-shaped tear through skin incision will be made. Orbicularis and periosteum will be dissected to expose the lacrimal sac fossa. Osteotomy of atleast 10 x 10 mm size will be performed using Kerrison bone punch. Lacrimal sac and nasal mucosal flaps will be fashioned. Excess of lacrimal sac will be excised. Syringing will be performed to confirm patency. If common canalicular block is noted, trephination with bicanalicular silicone tube intubation will be performed.  The flaps will be anastomosed using absorbable 6-0 sutures and wound will be closed in layers. Patch over the wound, and nasal packing with adrenaline 1:200000 solution will be done for 24 hours.

INTRA-OPERATIVE ANALYSIS:

The volume (in mL) of blood loss in each surgery will be noted. The intraoperative probing findings will be noted for common canalicular block, in cases of delayed external DCR surgery – to be considered for silicone intubation.

POST OPERATIVE CARE

The patients will be observed in ward for 24 hours and started on

·       Oral antibiotic– Tablet Ciprofloxacin (500mg 12 hourly, for 5 days)

·       Oral analgesic – Tablet Paracetamol (500 mg 8 hourly, for 3 days)

·       Oral antacid – Tablet Pantoprazole (40mg 24hourly, for 5 days)

·       Topical antibiotic –Tobramycin 0.3% Eye Drops (6 hourly for 2 weeks)

·       Nasal spray Xylometazoline (8 hourly, for two weeks)

·       Nasal spray fluticasone (8 hourly, for four weeks)

·       Topical Chloramphenicol ointment (12 hourly, for 10 days) for cases of External DCR

FOLLOW UP

-   Patients will be followed upto 6 months from the surgery.

-     Compulsory visits will be at day 1, day 7, 3 weeks, 6 weeks, 3 months and 6 months for all patients. External DCR surgery cases will be called at 2 weeks also for removal of skin sutures. Additional visits will be planned as needed for each case.

-     Presence of medial canthal swelling or discharge, epiphora in terms of Munk score, pain in terms of visual analog scale will be assessed.

-     Silicone intubation tube will be removed at completion of 6 weeks.

-     Syringing and endoscopic evaluation of internal ostium as per DCR ostium grading system, will be done in all cases at end of 6 months.

POST-OPERATIVE ANALYSIS:

·       Anatomical success will be defined as freely patent ostium on syringing.

·       Functional success will be defined as absence of subjective epiphora (Munk Score = 0)

OUTCOME MEASURE

Primary outcome will be percentage of anatomical and functional success at the end of follow-up period.

Secondary outcomes will be measured in terms of decrease in epiphora and pain, days for complete resolution of pain and swelling, endoscopic assessment of ostium, socioeconomic impact of treatment for acute dacryocystitis in terms of missed days of work, days with productivity < 50%, number of hospital visits total expense incurred for treatment; patient satisfaction in terms of cosmesis, complications of surgery, amount of blood loss during surgery, and need for additional interventions.

STATISTICAL ANALYSIS                                                                   

Normality will be assessed using Kolmogorov-Smirnoff test. Normally distributed data will be described using mean and standard deviation, and skewed data will be expressed using median and interquartile range. For evaluating changes in ordinal variables pre- and post-surgery, ANOVA and post-hoc analysis will be used. Categorical data will be analysed using chi-square test.

The SPSS version 25.0 will be used for statistical analysis. P-value <0.05 will be taken as significant.

ETHICAL CONSIDERATIONS:

1. The confidentiality of the subjects will be maintained throughout the study.

2. Informed consent will be taken from the study subjects.

3. Study subjects will be given an open choice to leave the study whenever they want to leave.

4. Approval from institutional ethics committee will be obtained and the study will be registered with Clinical trials registry of India (CTRI).