Proliferative Diabetic RetinopathyPhase 4NCT07640256

Pain Management During Panretinal Photocoagulation for Diabetic Retinopathy: Safety and Efficacy of Peribulbar Anesthesia

A Phase 4 study testing Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine and Tetracaine 5% drops in people with Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to compare two different anesthesia methods for pain control during panretinal photocoagulation (PRP), a type of laser surgery that treats proliferative diabetic retinopathy (PDR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Proliferative Diabetic Retinopathy
What is being tested?: Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine and Tetracaine 5% drops
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteMexico
Study dates: 6 Jul 2023to 21 Jun 2024
Phase: Phase 4
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

Adults aged 18 years or older with proliferative diabetic retinopathy
Scheduled to undergo their first PRP session
Able to maintain the required posture at the slit lamp throughout the procedure

Who cannot join

History of phobic anxiety disorder related to needles or injections
Known allergies or hypersensitivity to lidocaine, bupivacaine, or tetracaine
Use of analgesics within 24 hours prior to treatment
Cognitive or motor impairments that could hinder effective communication of pain.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
Mexico City, Mexico City, 04030

Other trials in Mexico

About this study

Official title: Safety and Efficacy of Peribulbar Anesthesia for Pain Management in Patients With Proliferative Diabetic Retinopathy During Panretinal Photocoagulation

The study included eyes from patients with diabetes and proliferative diabetic retinopathy who were scheduled to undergo their first PRP session. Participants were split into two groups to receive either peribulbar anesthesia, which is a type of anesthesia injected through the eyelid, or a sham injection with topical anesthesia only.

Pain on a numerical scale and vital signs were recorded before and for 15 minutes during PRP. These results were compared between the two groups to determine which method delivers superior pain control.

Conditions: Proliferative Diabetic Retinopathy
Being tested: Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine, Tetracaine 5% drops
Keywords: pain management, panretinal photocoagulation, proliferative diabetic retinopathy, peribulbar anesthesia
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaineDrug
A mixture of 1.5 mL of 0.5% bupivacaine and 1.5 mL of 2% lidocaine was prepared in a 3 mL syringe. The peribulbar injection was administered using a 25G needle inserted horizontally through the inferior palpebral conjunctiva, directed axially over the infraorbital rim, and then angled upward to deliver the anesthetic into the orbit.
Tetracaine 5% dropsDrug
A single drop of topical 5% tetracaine

Study groups in NCT07640256
Study group	Role	What they receive
Peribulbar anesthesia intervention group	Experimental	The intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection. Receives: Drug: Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine; Drug: Tetracaine 5% drops
Control group	Sham comparator	The control group received only topical anesthesia and a sham peribulbar injection. Receives: Drug: Tetracaine 5% drops

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain perception during PRP administration
patient perception of pain during PRP administration in each eye, measured using the Numerical Rating Scale (NRS). The NRS measures pain intensity on a scale of 0 to 10, where 0 corresponds to the absence of pain and 10 represents the worst pain imaginable.
Measured: Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

Secondary outcomes (3)

Heart rate
Heart rate measured as beats per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
Measured: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
Respiratory rate
Respiratory rate measured as breaths per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
Measured: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
Oxygen saturation
Oxygen saturation was measured as SpO2 using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
Measured: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202321 Jun 2024

First posted10 Jun 2026
Study start6 Jul 2023
Primary completion21 Mar 2024
Study completion21 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Proliferative Diabetic RetinopathyStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07640256
Sponsor's protocol ID: RET-PFC01
Status last verified: Jul 2026
First submitted: 1 Jun 2026
Last updated: 14 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified participant data will be made available to qualified researchers upon request to the corresponding author.

Publications

Kumar CM. Orbital regional anesthesia: complications and their prevention. Indian J Ophthalmol. 2006 Jun;54(2):77-84. doi: 10.4103/0301-4738.25826.
PubMed 16770022
Schobel HP, Ringkamp M, Behrmann A, Forster C, Schmieder RE, Handwerker HO. Hemodynamic and sympathetic nerve responses to painful stimuli in normotensive and borderline hypertensive subjects. Pain. 1996 Aug;66(2-3):117-24. doi: 10.1016/0304-3959(96)03079-5.
PubMed 8880832
McGrath PA. Psychological aspects of pain perception. Arch Oral Biol. 1994;39 Suppl:55S-62S. doi: 10.1016/0003-9969(94)90189-9.
PubMed 7702468
Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.
PubMed 11135722
Duker JS, Belmont JB, Benson WE, Brooks HL Jr, Brown GC, Federman JL, Fischer DH, Tasman WS. Inadvertent globe perforation during retrobulbar and peribulbar anesthesia. Patient characteristics, surgical management, and visual outcome. Ophthalmology. 1991 Apr;98(4):519-26. doi: 10.1016/s0161-6420(91)32262-0.
PubMed 2052307
Malik A, Fletcher EC, Chong V, Dasan J. Local anesthesia for cataract surgery. J Cataract Refract Surg. 2010 Jan;36(1):133-52. doi: 10.1016/j.jcrs.2009.10.025.
PubMed 20117717
Johari M, Moallem M, Amini A, Sanie-Jahromi F. Pain Management Strategies before Pan-Retinal Photocoagulation for Diabetic Retinopathy: A Systematic Review. J Ophthalmol. 2024 Aug 20;2024:6662736. doi: 10.1155/2024/6662736. eCollection 2024.
PubMed 39502493
Gonzalez VH, Wang PW, Ruiz CQ. Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not "1 and Done". Ophthalmology. 2021 Oct;128(10):1448-1457. doi: 10.1016/j.ophtha.2019.08.010. Epub 2019 Aug 21.
PubMed 31668888
Zakrzewski PA, O'Donnell HL, Lam WC. Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. Ophthalmology. 2009 Jun;116(6):1168-74. doi: 10.1016/j.ophtha.2009.01.022. Epub 2009 Apr 19.
PubMed 19376588
Mafrici M, Fragiotta S, Tarsitano MG, Lorenzi U, Toscani L. Topical anesthesia versus topical and subconjunctival anesthesia combined in diabetic retinopathy photocoagulation. Eur J Ophthalmol. 2024 Mar;34(2):529-533. doi: 10.1177/11206721231199206. Epub 2023 Aug 31.
PubMed 37654069
Tesha PE, Giavedoni LR, Berger AR, Altomare F, Chow DR, Navajas EV, Yoganathan P, Wong DT, Principe A. Subconjunctival lidocaine before laser treatment: a randomized trial. Ophthalmology. 2010 Sep;117(9):1810-4. doi: 10.1016/j.ophtha.2010.01.036. Epub 2010 Jun 8.
PubMed 20570360
Arruda MP, Hira S, Lima RV, Barbosa LIT, Zinher MT, Al-Sharif L, Leal Moreira JLM, Del Valle GS. Pharmacological therapy for relieving pain in panretinal photocoagulation: A network meta-analysis of randomized controlled trials. Surv Ophthalmol. 2025 Jul-Aug;70(4):645-652. doi: 10.1016/j.survophthal.2025.01.018. Epub 2025 Feb 5.
PubMed 39921002
Tsoumani AT, Asproudis IC, Damigos D. Tetracaine 0.5% eyedrops with or without lidocaine 2% gel in topical anesthesia for cataract surgery. Clin Ophthalmol. 2010 Sep 7;4:967-70. doi: 10.2147/opth.s11755.
PubMed 20856590
Richardson C, Waterman H. Pain relief during panretinal photocoagulation for diabetic retinopathy: a national survey. Eye (Lond). 2009 Dec;23(12):2233-7. doi: 10.1038/eye.2008.421.
PubMed 19169228
Wu WC, Hsu KH, Chen TL, Hwang YS, Lin KK, Li LM, Shih CP, Lai CC. Interventions for relieving pain associated with panretinal photocoagulation: a prospective randomized trial. Eye (Lond). 2006 Jun;20(6):712-9. doi: 10.1038/sj.eye.6701989. Epub 2005 Jul 8.
PubMed 16021194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
Not yet recruitingPhase 4
Continuous Delivery of Ranibizumab Via the Port Delivery System for Proliferative Diabetic Retinopathy-related Vitreous Hemorrhage With Pars Plana Vitrectomy and Limited PRP.
Proliferative Diabetic Retinopathy, Diabetic Retinopathy
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
RecruitingPhase 3
Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR
Proliferative Diabetic Retinopathy (PDR)
Recruiting
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All Proliferative Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Peribulbar Anesthesia for Pain Management in Patients With Proliferative Diabetic Retinopathy During Panretinal Photocoagulation
ClinicalTrials.gov ID: NCT07640256
Acronym / sponsor ID: RET-PFC01
Conditions: Proliferative Diabetic Retinopathy
Keywords: pain management, panretinal photocoagulation, proliferative diabetic retinopathy, peribulbar anesthesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
Study start: 6 Jul 2023 (actual)
Primary completion: 21 Mar 2024 (actual)
Study completion: 21 Jun 2024 (actual)
First posted: 10 Jun 2026 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Peribulbar anesthesia intervention group	Experimental	Drug: Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine, Drug: Tetracaine 5% dropsThe intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection.
Control group	Sham comparator	Drug: Tetracaine 5% dropsThe control group received only topical anesthesia and a sham peribulbar injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults aged 18 years or older with proliferative diabetic retinopathy
Scheduled to undergo their first PRP session
Able to maintain the required posture at the slit lamp throughout the procedure

Key exclusion criteria (4 listed)

History of phobic anxiety disorder related to needles or injections
Known allergies or hypersensitivity to lidocaine, bupivacaine, or tetracaine
Use of analgesics within 24 hours prior to treatment
Cognitive or motor impairments that could hinder effective communication of pain.

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
Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaineA mixture of 1.5 mL of 0.5% bupivacaine and 1.5 mL of 2% lidocaine was prepared in a 3 mL syringe. The peribulbar injection was administered using a 25G needle inserted horizontally through the inferior palpebral conjunctiva, directed axially over the infraorbital rim, and then angled upward to deliver the anesthetic into the orbit.	Drug	Peribulbar anesthesia intervention group
Tetracaine 5% dropsA single drop of topical 5% tetracaine	Drug	Control group, Peribulbar anesthesia intervention group

Primary outcome

Pain perception during PRP administration
Time frame: Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
patient perception of pain during PRP administration in each eye, measured using the Numerical Rating Scale (NRS). The NRS measures pain intensity on a scale of 0 to 10, where 0 corresponds to the absence of pain and 10 represents the worst pain imaginable.

3 secondary outcomes

Heart rate
Time frame: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
Respiratory rate
Time frame: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
Oxygen saturation
Time frame: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Background: PubMed 16770022Kumar CM. Orbital regional anesthesia: complications and their prevention. Indian J Ophthalmol. 2006 Jun;54(2):77-84. doi: 10.4103/0301-4738.25826.
Background: PubMed 8880832Schobel HP, Ringkamp M, Behrmann A, Forster C, Schmieder RE, Handwerker HO. Hemodynamic and sympathetic nerve responses to painful stimuli in normotensive and borderline hypertensive subjects. Pain. 1996 Aug;66(2-3):117-24. doi: 10.1016/0304-3959(96)03079-5.
Background: PubMed 7702468McGrath PA. Psychological aspects of pain perception. Arch Oral Biol. 1994;39 Suppl:55S-62S. doi: 10.1016/0003-9969(94)90189-9.
Background: PubMed 11135722Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.
Background: PubMed 2052307Duker JS, Belmont JB, Benson WE, Brooks HL Jr, Brown GC, Federman JL, Fischer DH, Tasman WS. Inadvertent globe perforation during retrobulbar and peribulbar anesthesia. Patient characteristics, surgical management, and visual outcome. Ophthalmology. 1991 Apr;98(4):519-26. doi: 10.1016/s0161-6420(91)32262-0.
Background: PubMed 20117717Malik A, Fletcher EC, Chong V, Dasan J. Local anesthesia for cataract surgery. J Cataract Refract Surg. 2010 Jan;36(1):133-52. doi: 10.1016/j.jcrs.2009.10.025.
Background: PubMed 39502493Johari M, Moallem M, Amini A, Sanie-Jahromi F. Pain Management Strategies before Pan-Retinal Photocoagulation for Diabetic Retinopathy: A Systematic Review. J Ophthalmol. 2024 Aug 20;2024:6662736. doi: 10.1155/2024/6662736. eCollection 2024.
Background: PubMed 31668888Gonzalez VH, Wang PW, Ruiz CQ. Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not "1 and Done". Ophthalmology. 2021 Oct;128(10):1448-1457. doi: 10.1016/j.ophtha.2019.08.010. Epub 2019 Aug 21.
Background: PubMed 19376588Zakrzewski PA, O'Donnell HL, Lam WC. Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. Ophthalmology. 2009 Jun;116(6):1168-74. doi: 10.1016/j.ophtha.2009.01.022. Epub 2009 Apr 19.
Background: PubMed 37654069Mafrici M, Fragiotta S, Tarsitano MG, Lorenzi U, Toscani L. Topical anesthesia versus topical and subconjunctival anesthesia combined in diabetic retinopathy photocoagulation. Eur J Ophthalmol. 2024 Mar;34(2):529-533. doi: 10.1177/11206721231199206. Epub 2023 Aug 31.
Background: PubMed 20570360Tesha PE, Giavedoni LR, Berger AR, Altomare F, Chow DR, Navajas EV, Yoganathan P, Wong DT, Principe A. Subconjunctival lidocaine before laser treatment: a randomized trial. Ophthalmology. 2010 Sep;117(9):1810-4. doi: 10.1016/j.ophtha.2010.01.036. Epub 2010 Jun 8.
Background: PubMed 39921002Arruda MP, Hira S, Lima RV, Barbosa LIT, Zinher MT, Al-Sharif L, Leal Moreira JLM, Del Valle GS. Pharmacological therapy for relieving pain in panretinal photocoagulation: A network meta-analysis of randomized controlled trials. Surv Ophthalmol. 2025 Jul-Aug;70(4):645-652. doi: 10.1016/j.survophthal.2025.01.018. Epub 2025 Feb 5.
Individual participant dataSharing planned: No. De-identified participant data will be made available to qualified researchers upon request to the corresponding author.

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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.

José Gerardo García Aguirre, MD principal investigator

Asociación Para Evitar la Ceguera en México, I.A.P.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jul 2026. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain perception during PRP administration (time frame: Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07640256, which also lists 29 linked publications.

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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.