| CTRI Number |
CTRI/2022/11/047163 [Registered on: 09/11/2022] Trial Registered Prospectively |
| Last Modified On: |
31/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
change in refractive power before and after pterygium excision |
|
Scientific Title of Study
|
Assessment of preoperative and postoperative changes in keratometry reading and corneal astigmatism after pterygium excision with conjunctival autograft transplantation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tahir Husain Ansari |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No.- 1069
Department of ophthalmology
Rohilkhand medical college and hospital , pilibhit bypass road , Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9012355563 |
| Fax |
|
| Email |
drtahir08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tahir Husain Ansari |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No.- 1069
Department of ophthalmology
Rohilkhand medical college and hospital , pilibhit bypass road , Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9012355563 |
| Fax |
|
| Email |
drtahir08@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Antariksh Agrawal |
| Designation |
PG resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Room No.- 1069
Department of ophthalmology
Rohilkhand medical college and hospital , pilibhit bypass road , Bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
6265127281 |
| Fax |
|
| Email |
agrawalantariksh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital, pilibhit bypass road , bareilly |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tahir Husain Ansari |
Rohilkhand Medical college and hospital |
Room No -1069 , department of ophthalmology Bareilly UTTAR PRADESH |
9012355563
drtahir08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H110||Pterygium of eye, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a primary ocular pterygium causing visual symptoms or for cosmetic reasons. |
|
| ExclusionCriteria |
| Details |
Recurrent Pterygium
Inflamed Pterygium
Pseudo Pterygium
Previous history of Corneal disease or degeneration
Previous history of intraocular surgery or eye trauma
Systemic diseases like collagen vascular disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of keratometry reading and corneal astigmatism after pterygium excision with conjunctival autograft transplantation. |
At post - operative day 1
At 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of difference in mean corneal curvature and to find out type of corneal astigmatism |
At 1 month post operatively |
|
|
Target Sample Size
|
Total Sample Size="107" Sample Size from India="107"
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)
|
15/11/2022 |
| 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
|
1-Ghiasian, Leila et al. “Recurrent Pterygium: A Reviewâ€. Journal of current
ophthalmology. 2022 33(4), 367-78.
2-Chevuturu, M. “Assessment of pre-operative and postoperative changes in corneal astigmatism after pterygium excision by different techniquesâ€. Asian journal of Medical research. 2020; 9(2), 1-4.
3-Garg P, Sahai A. “A comparative study of preoperative and postoperative changes in corneal astigmatism after pterygium excision by different techniques.â€Indian journal of ophthalmology. 2019;67,1036-39.
4-Shenoy D, Nazareth N. “Comparative study of Astigmatism before and after Pterygium Excision.â€IOSR Journal of Dental and Medical Sciences.2019;18(8),59-62 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pterygium is a wing shape fibrovascular degeneration of
subconjunctival tissue. It destroys bowman’s membrane
and corneal stroma
by proliferating as vascularized granulation tissue. Ultraviolet B the main etiological factor mutates p53 tumor
suppressor gene present
at limbal stem cell and leads to overexpression of
TGF-beta and VEGF which results in upregulation of collagenase,
cellular migration and angiogenesis. Elastotic degeneration of collagen and subepithelial fibrovascular tissue are the characteristic pathological feature
of the pterygium. Pterygia
are thick and vascular when early but becomes pale and thin when cease to
progress and leads to formation of
dense fibrous tissues and development of considerable corneal astigmatism. Pterygium
exerts a tractional force on cornea, which results in flattening of corneal
curvature in horizontal meridian
leading to with-the-rule astigmatism. Flattening also occurs due
to pooling of tears near the head of
pterygium. Most
patient of pterygium complaints of foreign body sensation, lacrimation,
redness, dryness and itching.
Spatial contrast sensitivity and glare disability are worsened in patients even when
the visual acuity is minimally affected. Cosmetic reasons, visual impairment,
motility restriction is some of
the indication for pterygium surgery. Pterygium
excision is the mainstay of treatment but
with high tendency to reoccur. The gold standard in
treatment of pterygium is pterygium excision with autograft implantation which has low rate
of recurrences and complication. The present study aims to evaluate keratometry
readings and corneal astigmatic changes following pterygium excision with
conjunctival autograft transplantation using fibrin glue. Since a few studies
have been done on this aspect therefore this study has been undertaken. |