| CTRI Number |
CTRI/2025/10/095785 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study in patients with cataract and pterygium to assess improvement in vision and corneal shape after combined cataract and pterygium surgery. |
|
Scientific Title of Study
|
Comparative study of pre operative and post operative Astigmatism outcome following Simultaneous Pterygium and Small Incision Cataract Surgery (SICS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKSHAYA TANDLE |
| Designation |
Postgraduate student |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Ophthalmology, ground floor, AVBRH building, Sawangi Meghe,Wardha Maharashtra,India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9820421538 |
| Fax |
|
| Email |
akshayatandle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SACHIN DAIGAVANE |
| Designation |
Professor and Head, Department of Ophthalmology |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Ophthalmology, ground floor, AVBRH building, Sawangi Meghe,Wardha Maharashtra,India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9121736568 |
| Fax |
|
| Email |
drsachin391977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SACHIN DAIGAVANE |
| Designation |
Professor and Head, Department of Ophthalmology |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Ophthalmology, ground floor, AVBRH building, Sawangi Meghe,Wardha Maharashtra,India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9121736568 |
| Fax |
|
| Email |
drsachin391977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education And Research,Sawangi, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Sawangi, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshaya Tandle |
Acharya Vinobha Bhave Rural Hospital |
Department of Ophthalmology,Ground floor, AVBRH building,Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
9820421538
akshayatandle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Preoperative Baseline Parameters |
Pre-operative baseline values of the same eye including type and degree of corneal astigmatism, uncorrected and best-corrected visual acuity, and pterygium size/grade. These will serve as comparator against post-operative values at Day 1, Day 15, and Day 30. |
| Intervention |
Simultaneous Pterygium Excision with Small Incision Cataract Surgery (SICS) |
All eligible patients with visually significant cataract and grade 1–2 nasal pterygium will undergo small incision cataract surgery (SICS) with intraocular lens implantation combined with pterygium excision under peribulbar anaesthesia.Duration of intervention is single day surgical procedure,30 to 45 minutes per patient and total duration per participant, including follow up is 30 days.Values will be taken on following days- Baseline that is pre operative, post operative day 1, post operative day 15 and post operative day 30. |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above 35 years of age
2) Male/Female
3) Patients diagnosed with visually significant cataract & pterygium
4) Patients with grade 1 and grade 2 pterygium
5) Patients with follow up of minimum 1month.
6) Participants who will give the informed consent |
|
| ExclusionCriteria |
| Details |
1) Patients with grade 3, 4 pterygium, any grade of recurrent pterygium, double headed
pterygium and temporal pterygium. 2) Patients with traumatic cataract, developmental cataract, congenital cataract, past refractive
surgeries. 3) Pre-existing diseases such as ocular diseases such as glaucoma or iridocyclitis, ocular
pathologies, retinal pathologies, pre existing opacities and corneal degeneration
4) Non dilating pupil |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
Change in type and amount of corneal astigmatism |
Baseline(Preoperative), post operative day 1, day 15 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes
1. Correlation between size/extent of pterygium and pre-operative astigmatism
2. Change in uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
3. Patient satisfaction with visual outcome
4. Incidence and types of complications affecting visual acuity and astigmatism outcomes |
Baseline(Preoperative),post operative day 1, day 15 and day 30 |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prospective comparative study to evaluate outcomes of simultaneous pterygium excision with small incision cataract surgery (SICS). Eighty-eight patients with visually significant cataract and grade 1–2 pterygium will be included. Preoperative evaluation: visual acuity, refraction, keratometry, axial length, intraocular pressure. Surgery: SICS with pterygium excision under peribulbar anesthesia. Follow-up: Day 1, Day 15, Day 30. Primary outcome: change in type and degree of corneal astigmatism. Secondary outcomes: correlation of pterygium size with astigmatism, improvement in uncorrected and best corrected visual acuity, patient satisfaction, intra- and postoperative complications. The study will assess refractive stability and visual results of simultaneous surgery to guide clinical decision making. |