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CTRI Number  CTRI/2020/07/026685 [Registered on: 20/07/2020] Trial Registered Prospectively
Last Modified On: 15/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   comparison in change of preop and postop MRD1(marginal reflex distance) in moderate to severe ptosis following closed posterior levator advancement surgery 
Scientific Title of Study   Evaluation of ptosis correction following closed posterior levator advancement 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr sonam singh 
Designation  PG 
Affiliation  maulana azad medical college and hospital 
Address  364, first floor, type 2 government quarters, mirdard lane, maulana azad medical college, new delhi

Central
DELHI
110002
India 
Phone  9654427072  
Fax    
Email  snmsingh194@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sushil kumar 
Designation  Professor 
Affiliation  maulana azad medical college and hospital 
Address  Ward 5, Ground Floor, Gurunanak Eye Center, Maharaja Ranjit Singh Marg, new delhi

New Delhi
DELHI
110002
India 
Phone  9654427072  
Fax    
Email  sushilkumar1958@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr sushil kumar 
Designation  Professor 
Affiliation  maulana azad medical college and hospital 
Address  Ward 5, Ground Floor, Gurunanak Eye Center, Maharaja Ranjit Singh Marg, new delhi

New Delhi
DELHI
110002
India 
Phone  9654427072  
Fax    
Email  sushilkumar1958@yahoo.com  
 
Source of Monetary or Material Support  
NOT APPLICABLE 
 
Primary Sponsor  
Name  Guru Nanak Eye Centre 
Address  Guru Nanak Eye Centre,Bahardur Shah Zafar Marg, New Dehli 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr sonam singh  Guru Nanak Eye Centre   Guru Nanak Eye Centre, bahadur shah zafar marg, new delhi
Central
DELHI 
9654427072

snmsingh194@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College and Associated Lok Nayak Hospital, GIPMER and GNEC Institute Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H024||Ptosis of eyelid,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Closed posterior levator advancement  CLOSED POSTERIOR LEVATOR ADVANCEMENT: · The eyes cleaned and draped after taking all aseptic precautions. · Injection 2% lignocaine with 1:80,000 adrenaline will be administered in the tissue plane between Muller’s muscle and conjunctiva. · The lid will be marked for the lid crease and exit position of suture. · The lid will be double everted over Desmarres retractor. Three points will be marked on the fornceal side of conjunctiva, first in the center of the tarsus, second point 5mm lateral and the third point 5mm medial to central point. · On these marking, stay sutures will be placed through conjunctival and Muller’s muscle. · A ptosis clamp will be placed followed by continuous key pattern suturing. · If the ptosis is severe with good phenylepherine response, 10mm of Muller’s muscle will be resected. Additional resection of tarsus will be used if suboptimal phenylepherine response is observed. Excision of tarsus will be performed in 1:1 ratio of further elevation (mm) desired. · Blade will be used to resect the tissue below the clamp and above the running suture. · Pressure will be applied for few minutes to control the bleeding. · Revision surgery will be performed if MRD1 is not within 1mm of the desired height (symmetry within 1mm of fellow eye).  
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Moderate or Severe ptosis
Involutional ptosis
Congenital ptosis
LPS action more than or equal to 5mm 
 
ExclusionCriteria 
Details  Marcus gunn jaw winking syndrome
Myasthenic ptosis
Horner’s syndrome
Third nerve palsy
Post-traumatic ptosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be measured in terms of change in MRD1  Primary outcome will be measured in terms of change in MRD1 at Postoperative day 1,1week, 2week, 4week, 6week, 3month and 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be measured in terms of eyelid contour, complications and revision rate   6months 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="17" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

                                                                                     AIM AND OBJECTIVES

                                                                                  To assess the ptosis correction following Closed Posterior Levator Advancement (CPLA)

Ptosis, also known as blepharoptosis, refers to drooping of upper eyelid to a level lower than normal position. Normally the upper lid covers about one-sixth of the cornea, i.e. about 2mm.

Ptosis may either be congenital or acquired.

Crowell Beard classified ptosis as follows4:

·         Congenital ptosis: It is associated with superior rectus weakness / blepharophimosis / Synkinetic ptosis (Marcus jaw winking ptosis)/ Third nervepalsy

·         Acquired ptosis: Neurogenic / Myogenic / Traumatic / Mechanical

The majority of cases of blepharoptosis are congenital, with the reported frequency varying between 62% to 90%1, 2, 3. Congenital ptosis is often due to the poor development of the levator muscle or its replacement by fibrosis, fat, or areolar tissue. Aponeurotic ptosis, also known as involutional or senile ptosis, is a form of acquired ptosis which occurs as a result of levator aponeurosis dehiscence or disinsertion. Surgery in aponeurotic ptosis is indicated in cases of visual axis obscuration and when better cosmesis isrequired.

Evaluation of ptosis includes assessment of visual acuity, strabismus, levator action, Bell’s phenomenon and other abnormalities like superior rectus weakness, blepharophimosis syndrome, synkinetic movements, anisometropia and amblyopia.

Management of ptosis depends on multiple factors like type, severity, levator function, Bell’s phenomenon, co-existence of superior rectus weakness, presence of synkinetic movements and blepharophimosis. Options include Fasanella-Servat procedure, levator resection and advancement, Muller’s muscle-conjunctival resection and traditional frontalis suspension procedures. In general, a patient with severe ptosis and poor levator function is a good candidate for frontalis sling while a person with minimum ptosis with good levator function is suitable for Fasanella-Servat procedure. Moderate-to-severe ptosis is usually treated via an anterior eyelid approach utilising plication, advancement, or resection of LPS5-6. Success rates of levator resection have been variably quoted from 70% to 90%. Rates of cosmetically unsatisfactory eyelid crease and contour abnormalities along with higher revision rates of up to 11% to 30% have been with levator resection5-7. Muller’s Muscle-Conjunctival Repair (MMCR) is another surgery for correction of mild-moderate ptosis but has not been widely used for severe ptosis. However,  some recent data suggest that MMCR may be helpful in a wider array of ptosis8-10.


Oh et al 11 recently published a new technique that involves an advancement of the levator muscle in a closed posterior eyelid approach. The technique has achieved satisfactory outcomes in patients with severe involutional ptosis with good levator function (more than or equal to 10mm), with good cosmetic results and minimal revision rate.

 

In this study, we aim to perform closed posterior levator advancement in patients with moderate to severe ptosis with levator action more than or equal to 5mm.

 

LACUNAE IN EXISTING KNOWLEDGE

To the best of our knowledge, there is paucity of literature on Ptosis correction following Closed Posterior Levator Advancement (CPLA) in:

1.        Congenital ptosis

2.        Indian population.

MATERIALS AND METHODS

 

STUDY DESIGN: Prospective Interventional Study

 

PLACE OF STUDY: Guru Nanak Eye Centre (OPD and Oculoplasty clinic)

 

STUDY DURATION: 12 months

 

SAMPLE SIZE:

     As per the formula:

According Oh et al11 2018, significant ptosis correction was seen in 96% cases, however standard deviation is not mentioned in the article. Thus using the Margin reflex distance1 (MRD1),

Pre-operative mean = 0.3mm, post-operative mean = 3.5mm and thus, the mean difference in MRD1 is 3.22mm. As the difference is large, we have assumed the effect size to be larger. Therefore we have used the effect size = 0.7 (large).

Level of significance, α = 5%

Power (1-ß) = 80%

The formula used to calculate sample size was:

Where Zα = 1.960 for α = 5%, Zβ = 0.842 and effect size = 0.7

So, n = 17 subjects

 

STUDY POPULATION: Study will comprise of 17 patients meeting the inclusion and exclusion  criteria.

INCLUSION CRITERIA: All patients with -

1.             Involutional ptosis

2.             Congenital ptosis of age ≥5 years

3.             Moderate (amount of ptosis 3mm)  or severe (amount of ptosis ≥ 4mm) ptosis

4.             LPS action more than or equal to 5mm

EXCLUSION CRITERIA:

1.      Marcus gunn jaw winking syndrome

2.      Myasthenic ptosis

3.      Horner’s syndrome

4.      Third nerve palsy

5.      Post-traumatic ptosis

 


 

PRE-TREATMENT EVALUATION

 

HISTORY:

A detailed history regarding onset and progression of the disease and evaluation of possible causative factor like trauma or surgery will be taken. Also history of diplopia, spectacle use, occlusion therapy, redness or diurnal variation will be elicited.

OPHTHALMOLOGICAL EXAMINATION:

1.      Unaided/aided and best corrected visual acuity

2.      Retinoscopy under appropriate cycloplegic agent

3.      Assessment of ocular alignment and motility

4.      Assessment of ptosis

·      Type of ptosis

·       Degree of ptosis (difference in MRD1 of normal and Ptotic eye)

·      Margin crease height (distance from upper eyelid crease to the eyelid margin)

·      HPA (distance form medial canthus to lateral canthus)

·      VPA (widest point between the lower eyelid and upper eyelid)

·      MRD1 (distance from the upper eyelid margin to the corneal light reflex in primary position)

·      MRD2  (distance from the lower eyelid margin to the corneal light reflex in primary position)

·      LPS action (measuring from downgaze to upgaze with frontalis muscle action negated)

·      Bell’s phenomenon

5.      Schirmer’s test

6.      10% Phenylephrine response

7.      Clinical photographs

BLOOD INVESTIGATIONS:

·         Bleeding time

·         Clotting time

·         Haemoglobin

 

SURGICAL TECHNIQUE:

Surgery will be performed under either local anesthesia (2% lignocaine with 1:80,000 adrenaline) or general anesthesia.

CLOSED POSTERIOR LEVATOR ADVANCEMENT:

·         The eyes cleaned and draped after taking all aseptic precautions.

·         Injection 2% lignocaine with 1:80,000 adrenaline will be administered in the tissue plane between Muller’s muscle and conjunctiva.

·         The lid will be marked for the lid crease and exit position of suture.

·         The lid will be double everted over Desmarres retractor. Three points will be marked on the fornceal side of conjunctiva, first in the  center of the tarsus, second point 5mm lateral and the third point 5mm medial to central point.

·         On these marking, stay sutures will be placed through conjunctival and Muller’s muscle.

·         A ptosis clamp will be placed followed by continuous key pattern suturing.

·         If the ptosis is severe with good phenylepherine response, 10mm of Muller’s muscle will be resected. Additional resection of tarsus will be used if suboptimal phenylepherine response is observed. Excision of tarsus will be performed in 1:1 ratio of further elevation (mm) desired.

·         Blade will be used to resect the tissue below the clamp and above the running suture.

·         Pressure will be applied for few minutes to control the bleeding.

·         Revision surgery will be performed if MRD1 is not within 1mm of the desired height (symmetry within 1mm of fellow eye). 

 

POST-OPERATIVE TREATMENT:

·         Tablet Ciprofloxacin (500 mg 12 hourly) and Tablet Ibuprofen (400 mg 8 hourly) for five days

·         Topical Tobramycin 0.3% (in children) or Ofloxacin 0.3% (in adults) four times a day for two weeks

·         Topical Carboxymethylcellulose 0.5% (4-6 times a day) and ointment Hypromellose ( at bed time) depending on Bell’s phenomenon.

·         Ointment Tobramycin 0.3% for local application over wound for 10 days.

·         Skin suture removal will be done on day 10 post-op.

 

    FOLLOW UP

   Patients will be followed up to 6 months from the post-operative day1 (table 1).


    POST OP EVALUATION:

 

 

Post-op

day1

1stweek

2ndweek

4thweek

6thweek

3rd month

6thmonth

MRD1

√

√

√

√

√

√

√

Lid contour

√

√

√

√

√

√

√

Lagophthamos

√

√

√

√

√

√

√

Bell’s phenomenon

√

√

√

√

√

√

√

Schirmer’s test

√

√

√

√

√

√

√

Corneal abrasion

√

√

√

√

√

√

√

Revision Rate

-

-

-

-

-

√

 

 

OUTCOME MEASURE

Primary outcome will be measured in terms of change in MRD1.

Secondary outcome will be measured in terms of eyelid contour, complications and revision rate.

 

STATISTICAL ANALYSIS

Data of study proforma will be entered in MS excel. Statistical analysis will be performed on SPSS version 25. For evaluating the change, Wilcoxon signed rank test will be applied. For categorical data chi square test will be applied.

p <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 the study.


 
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