| CTRI Number |
CTRI/2025/05/087449 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study Outcomes of Cataract Surgery in Eyes with Coloboma |
|
Scientific Title of Study
|
Cataract surgery with associated coloboma: predictors of outcome and safety of different surgical techniques |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Ophthalmology,Ground Floor
AVBRH building ,Sawangi Meghe
Wardha MAHARASHTRA 442001 India |
| Phone |
7798166923 |
| Fax |
|
| Email |
sharma.ashish23788@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shashank Banait |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Ophthalmology,Ground Floor
AVBRH building ,Sawangi Meghe
Wardha MAHARASHTRA 442001 India |
| Phone |
9822226124 |
| Fax |
|
| Email |
shashankbanait@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashank Banait |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Of Ophthalmology,Ground Floor
AVBRH building ,Sawangi Meghe
Wardha MAHARASHTRA 442001 India |
| Phone |
9822226124 |
| Fax |
|
| Email |
shashankbanait@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research, Sawangi Meghe, Wardha,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha,India 442001 |
| 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 Ashish Sharma |
Acharya Vinobha Bhave Rural Hospital |
Department of Ophthalmology
AVBRH building
Ground floor
Sawangi Meghe Wardha MAHARASHTRA |
7798166923
sharma.ashish23788@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q130||Coloboma of iris, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual Small Incision Cataract Surgery |
A scleral corneal tunnel will be made in patients with Iris Coloboma and capsulorhexis will be done after placing the CTR ring and lens will be implanted in 20 minutes
|
| Comparator Agent |
Phacoemulsification |
Clear Corneal Incision will be made in patients with Iris Coloboma and then pupil will be enlarged using the CTR ring and capsulorhexis will be done and lens will be implanted in 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with coloboma and having cataract
2. Patients with no history of previous ocular surgery in operating eye
|
|
| ExclusionCriteria |
| Details |
1. Patients having other ocular comorbidities injuries or surgery
2. Cases with premature entry or where valve could not be formed properly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved postoperative visual outcomes and reduced surgical complications |
Assessment will be made at postoperative six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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
|
Coloboma,
a congenital defect due to incomplete embryonal fissure closure, often
affects the infero-nasal part of the fundus & is frequently associated with
cataracts, a leading treatable cause of visual impairment. However, cataract
surgery in colobomatous eyes presents significant challenges due to anatomical
anomalies such as microcornea, zonular instability, poor pupillary dilation,
& structural irregularities. This hospital-based
observational study, done at Ophthalmology Department Acharya Vinobha Bhave
Rural Hospital, Sawangi, over two years aiming to evaluate the outcomes &
safety of cataract surgery techniques, including phacoemulsification (PE) &
manual small incision cataract surgery (M-SICS). The surgery type will depend on
the degree of microcornea, cataract hardness, & zonular stability.
Preoperative, intraoperative, & postoperative assessments will include
detailed ophthalmic evaluations, visual acuity measurements, grading of
microcornea, & complications such as corneal edema, using standardized
grading systems. Statistical analysis using SPSS will identify predictors of
surgical outcomes, with significance at p < 0.05. The study seeks to improve
surgical techniques, enhance patient safety, & provide insights into counselling
& risk stratification for individuals with coloboma-associated cataracts.
By considering these challenges, the study
aims to optimize functional outcomes & quality of life for affected
patients. The study is expected to demonstrate improved
postoperative visual outcomes, reduced surgical complications, & enhanced
safety in cataract surgery for colobomatous eyes. |