| CTRI Number |
CTRI/2025/02/080594 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating surgical outcomes in patients with non-dilating pupils undergoing cataract surgery |
|
Scientific Title of Study
|
Assessment of surgical outcome in patient with nondilating pupil undergoing phacoemulsification |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Donthula Gayathri |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8333801583 |
| Fax |
|
| Email |
gayathricooldonthula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sachin Daigavane |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8333801583 |
| Fax |
|
| Email |
Drsachin391977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Daigavane |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
MAHARASHTRA
442001
India |
| Phone |
8333801583 |
| Fax |
|
| Email |
Drsachin391977@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences Sawangi Meghe Wardha |
| Address |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, 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 Sachin Daigavane |
Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA |
8333801583
Drsachin391977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 40 years and above. Patients diagnosed with cataracts. Patients with non-dilating pupil. Patients scheduled for phacoemulsification surgery. Patients who provide written consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
Patients with traumatic Cataracts. Patients with subluxated Cataracts. Patients diagnosed with glaucoma. Patients with complicated cataracts accompanied by uveitis or associated posterior segment issues. Patients with a history of previous intraocular surgery. Diabetic patients with existing diabetic retinopathy changes. Patients with pre-existing retinal or macular diseases. Patients unwilling to provide consent for participation in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative improvement in Best Corrected Visual Acuity (BCVA), assessed using a Snellen chart or equivalent, and the reduction in postoperative complications such as glare and photophobia. |
Day 1, Week 1, and 1 Month Post-Surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of postoperative glare and photophobia, along with changes in intraocular pressure (IOP) and corneal status (e.g., edema or endothelial cell count). |
Day 1, Week 1, and 1 Month Post-Surgery. |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
01/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective observational cohort study aims to evaluate the surgical outcomes in patients with non-dilating pupils undergoing phacoemulsification at a tertiary care hospital in Central India. The study focuses on comparing the efficacy and safety of three intraoperative techniques—stretch pupilloplasty/sphincterotomy, iris hooks, and pupillary expanders (B Hex Ring or GUPTA Ring)—in managing non-dilating pupils. Outcomes of interest include visual acuity improvement, postoperative complications, and overall surgical success, assessed at specific postoperative intervals. Findings are expected to provide evidence-based guidance for optimizing surgical strategies in such complex cases. |