Macular EdemaNCT01023113
To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
A study testing PASCAL laser and Conventional laser in people with Macular Edema and Diabetic Retinopathy, run by L.V. Prasad Eye Institute at 1 site in India.
Trial summary
Lacunae in Knowledge No study is available in literature regarding visual field impairment in proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal photocoagulation with PASCAL panretinal photocoagulation AIMS \& OBJECTIVE 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Diabetic Retinopathy, Visual Field Loss
- What is being tested?
- PASCAL laser and Conventional laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 eyes of diabetic patients with proliferative DR will be included.
- Visual acuity 20/50 or better in all patients.
- Patients available for follow up at least twice between 4-12 weeks.
- Patients giving consent for panretinal photocoagulation and for inclusion in study
Who cannot join
- Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study.
- Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
LV Prasad Eye Institute
Hyderabad, A.P., 500034
Nand Kishore, M.D., 04030612607, narayanan@lvpei.org
Raja Narayanan, M.D.
About this study
Lacunae in Knowledge No study is available in literature regarding visual field impairment in proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal photocoagulation with PASCAL panretinal photocoagulation
AIMS \& OBJECTIVE
- To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation.
- To examine the effect of these modalities of laser on macular edema
60 eyes of proliferative diabetic retinopathy will undergo humphery visual field analysis,and optical coherence tomography before and after panretinal photocoagulation
Read the detailed description
Material and Methods
1.Study will be prospective randomized interventional case series. Methods: 60 eyes of proliferative diabetic retinopathy (clear media with no vitreous/significant preretinal hemorrhage) will be taken for the study, out of which 30 eyes will undergo panretinal photocoagulation by conventional frequency doubled Nd: YAG laser and remaining 30 eyes will be by PASCAL laser.
All patients will undergo routine ophthalmic examination (visual acuity, slit lamp, indirect ophthalmoscope, IOP) as well as FFA/seven fields fundus photos (whenever required), OCT(optoview spectral domain OCT), visual fields (Humphrey 30-2 SITA Standard and 60-1) and baseline blood investigation will be done before 1st sitting of laser. Written informed consent will be taken by all the subjects. PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery. In case of clinical significant macular edema modified grid/ focal laser of mild intensity spots will be done. At each visit patient will be assessed for visual acuity, OCT, IOP (applanation tonometer). Patients will be followed up for at least 3 months. After the completion of last sitting of photocoagulation, follow-up will be at one month and 3 months. At one month follow up together with routine ophthalmic examination, OCT, HVF 30-2,60-1 will be done. At final follow-up at 3 months HVF 30-2,60-1,OCT will be done in addition of routine ophthalmic examination and FFA will be done whenever indicated.
Inclusion Criteria
- 60 eyes of diabetic patients with proliferative DR will be included.
- Visual acuity 20/50 or better in all patients.
- Patients available for follow up at least twice between 4-12 weeks.
- Patients giving consent for panretinal photocoagulation and for inclusion in study
Exclusion Criteria
- Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study.
- Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.
Out come Measure
- Comparison of the two methods in relation to visual field loss(in previous studies average deterioration in visual field(MD) was 3-5dB in 45% cases) in terms of MD,CPSD and each quadrants loss of fields and number of patients worsened the visual fields and which method will be superior in term of less visual field loss.
- Effect on macular edema in terms of OCT thickness
- Conditions
- Macular Edema, Diabetic Retinopathy, Visual Field Loss
- Being tested
- PASCAL laser, Conventional laser
- Keywords
- Diabetic retinopathy, laser, field loss, macular edema, Visual field loss
- Medical subject headings
- Macular Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASCAL laserProcedure or surgery
PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery
Conventional laserProcedure or surgery
PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery
| Study group | Role | What they receive |
|---|---|---|
| PASCAL laser, PRP in 2-3 sitting at 3 days interval. | Experimental | PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by PASCAL laser Receives: Procedure: PASCAL laser |
| Conventional laser | Active comparator | PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by conventional laser Receives: Procedure: Conventional laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields
Measured: 3 months
Secondary outcomes (1)
Effect on macular edema in terms of OCT thickness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L.V. Prasad Eye Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023113
- Sponsor's protocol ID
- nand2010
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
- ClinicalTrials.gov ID
- NCT01023113
- Acronym / sponsor ID
- nand2010
- Conditions
- Macular Edema, Diabetic Retinopathy, Visual Field Loss
- Keywords
- Diabetic retinopathy, laser, field loss, macular edema, Visual field loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- L.V. Prasad Eye InstituteUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lacunae in Knowledge No study is available in literature regarding visual field impairment in proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal photocoagulation with PASCAL panretinal photocoagulation
AIMS \& OBJECTIVE
- To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation.
- To examine the effect of these modalities of laser on macular edema
60 eyes of proliferative diabetic retinopathy will undergo humphery visual field analysis,and optical coherence tomography before and after panretinal photocoagulation
Detailed description
Material and Methods
1.Study will be prospective randomized interventional case series. Methods: 60 eyes of proliferative diabetic retinopathy (clear media with no vitreous/significant preretinal hemorrhage) will be taken for the study, out of which 30 eyes will undergo panretinal photocoagulation by conventional frequency doubled Nd: YAG laser and remaining 30 eyes will be by PASCAL laser.
All patients will undergo routine ophthalmic examination (visual acuity, slit lamp, indirect ophthalmoscope, IOP) as well as FFA/seven fields fundus photos (whenever required), OCT(optoview spectral domain OCT), visual fields (Humphrey 30-2 SITA Standard and 60-1) and baseline blood investigation will be done before 1st sitting of laser. Written informed consent will be taken by all the subjects. PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery. In case of clinical significant macular edema modified grid/ focal laser of mild intensity spots will be done. At each visit patient will be assessed for visual acuity, OCT, IOP (applanation tonometer). Patients will be followed up for at least 3 months. After the completion of last sitting of photocoagulation, follow-up will be at one month and 3 months. At one month follow up together with routine ophthalmic examination, OCT, HVF 30-2,60-1 will be done. At final follow-up at 3 months HVF 30-2,60-1,OCT will be done in addition of routine ophthalmic examination and FFA will be done whenever indicated.
Inclusion Criteria
- 60 eyes of diabetic patients with proliferative DR will be included.
- Visual acuity 20/50 or better in all patients.
- Patients available for follow up at least twice between 4-12 weeks.
- Patients giving consent for panretinal photocoagulation and for inclusion in study
Exclusion Criteria
- Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study.
- Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.
Out come Measure
- Comparison of the two methods in relation to visual field loss(in previous studies average deterioration in visual field(MD) was 3-5dB in 45% cases) in terms of MD,CPSD and each quadrants loss of fields and number of patients worsened the visual fields and which method will be superior in term of less visual field loss.
- Effect on macular edema in terms of OCT thickness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASCAL laser, PRP in 2-3 sitting at 3 days interval. | Experimental | Procedure: PASCAL laserPRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by PASCAL laser |
| Conventional laser | Active comparator | Procedure: Conventional laserPRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by conventional laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 eyes of diabetic patients with proliferative DR will be included.
- Visual acuity 20/50 or better in all patients.
- Patients available for follow up at least twice between 4-12 weeks.
- Patients giving consent for panretinal photocoagulation and for inclusion in study
Key exclusion criteria (2 listed)
- Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study.
- Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASCAL laserPRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery | Procedure or surgery | PASCAL laser, PRP in 2-3 sitting at 3 days interval. |
| Conventional laserPRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery | Procedure or surgery | Conventional laser |
Primary outcome
Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields
Time frame: 3 months
1 secondary outcome
Effect on macular edema in terms of OCT thickness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASCAL laser and Conventional laser in people with Macular Edema and Diabetic Retinopathy, run by L.V. Prasad Eye Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nand Kishore, M.D. (04030612607, narayanan@lvpei.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009; AzTrials last refreshed its copy on 31 Oct 2026.