| CTRI Number |
CTRI/2025/07/091369 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study to evaluate the effects of laser on accommodation, pupil size and contrast sensitivity |
|
Scientific Title of Study
|
Panretinal photocoagulation induced alterations in accommodation, pupillary parameters and contrast sensitivity: A prospective study in patients with proliferative diabetic retinopathy |
| 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 Prajakta Pawar |
| Designation |
Primary DNB resident (ophthalmology) |
| Affiliation |
Sankara eye hospital, Shivamogga |
| Address |
Opd no 24
Department of Retina
Sankara eye hospital, Thirthahalli road, Harakere, Shivamogga, pincode 577202 Karnataka, India
Shimoga
KARNATAKA
577202
India |
| Phone |
9860026101 |
| Fax |
|
| Email |
drprajaktapawar1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravishankar H N |
| Designation |
Senior consultant Vitreoretinal surgeon |
| Affiliation |
Sankara eye hospital, Shivamogga |
| Address |
Opd no 24
Department of Retina
Sankara eye hospital, Thirthahalli road, Harakere, Shivamogga, pincode 577202
Karnataka, India
Shimoga
KARNATAKA
577202
India |
| Phone |
9880312124 |
| Fax |
|
| Email |
ravishankar@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Pawar |
| Designation |
Primary DNB resident (ophthalmology) |
| Affiliation |
Sankara eye hospital, Shivamogga |
| Address |
Opd no 24
Department of Retina
Sankara eye hospital, Thirthahalli road, Harakere, Shivamogga, pincode 577202
Karnataka, India
Shimoga
KARNATAKA
577202
India |
| Phone |
9860026101 |
| Fax |
|
| Email |
drprajaktapawar1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital, Thirthahalli road, Harakere, Shivamogga, pincode 577202
Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Sankara eye hospital, Shivamogga |
| Address |
Sankara eye hospital, Thirthahalli road, Harakere, Shivamogga, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prajakta Pawar |
Sankara eye hospital |
Opd no 24, Sankara eye hospital, Thirthahalli road, Harakere, Shivamogga, pincode 577202, Karnataka, India
Shimoga
KARNATAKA |
9860026101
drprajaktapawar1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Sankara Eye Hospital, Shimoga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Eyes with proliferative diabetic retinopathy requiring panretinal photocoagulation
2 Patients willing to give consent for study and follow up
3 Eyes with pupils reacting to light
|
|
| ExclusionCriteria |
| Details |
1 Macular edema requiring anti-VEGF therapy
2 Eyes with pupillary abnormalities such as coloboma, iris atropy, rubeosis iridis, sectoral iris loss
3 Eyes with hazy media
4 Eyes with other retinal disorders or optic nerve damage
5 Eyes requiring surgery for advanced diabetic eye disease
6 Past history of cataract surgery
7 Eyes developing vitreous hemorrhage after PRP within 4 months
8 Eyes presenting with posterior synechiae
9 Eyes with non-reacting pupils
10 Eyes with traumatic mydriatic pupils
11 Eyes presenting with pseudoexfoliation syndrome
12 Eyes developing macular edema after PRP (even after 1 month or 1st PRP sitting)
13 Eyes undergoing any surgical interventions before or in between follow-up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To measure the change in pupil size in photopic, mesopic and scotopic illumination conditions after PRP
2 To measure the change in amplitude of accommodation and change in near point of accommodation following PRP
3 To measure the change in contrast sensitivity following PRP
|
Recorded before 1st PRP sitting then follow-up 1 month and 3 month after completion of PRP. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/08/2025 |
| 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="6"
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
|
Diabetic retinopathy is a serious eye disease caused by diabetes, where high blood sugar levels damage the blood vessels in the retina. Oxidative stress induced hyperglycemia is the key event in the pathogenesis of diabetic retinopathy. This damage can lead to vision impairment and, in advanced stages, blindness. Diabetic retinopathy progresses through various stages as non proliferative diabetic retinopathy NPDR and proliferative diabetic retinopathy PDR. Panretinal photocoagulation PRP is a type of laser treatment used to reduce the risk of severe vision loss in patients with proliferative diabetic retinopathy PDR or other retinal diseases. It involves applying controlled laser burns to peripheral retina, promoting selective photocoagulation, significantly reduces the oxygen demand of peripheral retina, leading to decrease production of vascular endothelial growth factor(VEGF) and other angiogenic factors. The study will evaluate the effect of PRP on accommodation, pupillary parameters and contrast sensitivity before PRP sitting , 1 month and 3 month after completion of PRP. The pupillary parameters will be assessed in photopic, mesopic and scotopic illumination conditions. |