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$: TransPRK - eye-tech-solutions.com · Epithelial Healing and Clinical Outcomes in Excimer Laser Photorefractive ... A Clinical and Confocal Microscopic Comparison of Transepithelial$
Soheil Adib-Moghaddam, MD

Trans-PRK Research Group, Tehran. Iran - Universal Council of Ophthalmology, USERN, Tehran, Iran

SCHWIND Sessions at the Booth, XXXV ESCRS Lisbon, October 2017

TransPRK PAST, PRESENT, FUTURE

TransPRK Research Group

TRANSPRK EVOLUTION AT A GLANCE

PAST: BEFORE WE STARTED

Section I


PUBLICATIONS BEFORE WE STARTED, AT A GLANCE

1. Comparison of Mechanical and Transepithelial Debridement during Photorefractive

Keratectomy (Clinch TE et al. 1999; Ophthalmology)

2. Epithelial Healing and Clinical Outcomes in Excimer Laser Photorefractive Surgery

Following Three Epithelial Removal Techniques: Mechanical, Alcohol, and Excimer

Laser (Lee HK et al. Epithelial Healing and Clinical Outcomes in Excimer Laser

Photorefractive Surgery Following Three Epithelial Removal Techniques: Mechanical,

Alcohol, and Excimer Laser. 2005; AJO)

3. A New Transepithelial Phototherapeutic Keratectomy Mode Using the NIDEK CXIII

Excimer Laser (Buzzonetti L et al. A New Transepithelial Phototherapeutic

Keratectomy Mode Using the NIDEKCXIII Excimer Laser. Journal of Refractive

Surgery. 2009 Jan 1;25(1):S122-4.)

4. Transepithelial photorefractive keratectomy: Clinical results (Fadlallah et al.

Transepithelial photorefractive keratectomy: clinical results. Journal of Cataract &

Refractive Surgery. 2011 Oct 31;37(10):1852-7.)


COMPARISON OF MECHANICAL AND TRANSEPITHELIAL DEBRIDEMENT DURING PHOTOREFRACTIVE KERATECTOMY

The 1st prospective evidence about two-step TransPRK: PTK + PRK • Purpose: Comparison of clinical results from mechanical and transepithelial debridement during photore-

• fractive keratectomy

• Conclusion:

Clinical results were not statistically different between the two techniques

Mechanical technique tended to have superior values for almost all tested parameters

Clinch TE et al. 1999; Ophthalmology


TRANSEPITHELIAL PHOTOREFRACTIVE KERATECTOMY: CLINICAL RESULTS

The 1st clinical study on Single-step TransPRK • Purpose: To assess the effectiveness, safety, and comfort of transepithelial photorefractive keratectomy (PRK) using the

Amaris laser platform.

• Conclusion: Transepithelial PRK for mild to moderate myopia with or without astigmatism was

Safe

Easier to perform than conventional PRK

Less pain Less postoperative haze A faster healing time The visual outcomes with the 2 techniques were comparable.

Fadlallah A, Fahed D, Khalil K, Dunia I, Menassa J, El Rami H, Chlela E, Fahed S. Transepithelial photorefractive keratectomy: clinical results. Journal of Cataract & Refractive Surgery. 2011 Oct 31;37(10):1852-7.


WHAT WE KNEW ABOUT SINGLE-STEP TRANSPRK BEFORE WE STARTED

• Almost comparable visual outcomes compared to other surgical modalities.

• Faster procedure

• Faster epithelial healing

• Less pain

• Less haze

TRANSPRK RESEARCH GROUP; NOW A PART OF:

UNIVERSAL COUNCIL OF OPHTHALMOLOGY (UCO-USERN)

Section II


CURRENT ORGANIZATION

Soheil Adib-Moghaddam

Founder

Ioannis Pallikaris

Advisor Samuel Arba Mosquera

Supervisor

Harilaos Ginis

Supervisor

Saeed Soleyman-Jahi

Managing Director

Established in 2010


OUR PUBLICATIONS AT A GLANCE

• 25 total scholarly publications

• 4 papers published

• 4 other under review

• 21 abstract presentations

• AAO

• ESCRS

• ASCRS

• WOC

• ISRS


SCIENTIFIC CONTRIBUTION HIGHLIGHTS

• Preliminary introduction of:

• Refined Single-step TransPRK

• Iran regimen

• Publication of the first results of single-step TransPRK in hyperopic eyes.

• Bi-central study with Aschaffenburg clinic of Germany

• Publication of the longest prospective follow-up data results for myopic eyes

undergoing single-step TransPRK

• Publication of the first prospective vector analysis results for myopic single-step

TransPRK

• Upcoming international multi-center projects

CONVENTIONAL SINGLE-STEP TRANSPRK

Section II-a: TransPRK Research Group Publications



1. Transepithelial PRK (T PRK) Mode, Using Schwind Amaris 500 Hz Excimer Laser (Adib-Moghaddam S. ESCRS XXIX, 17-21 September 2011, Vienna, Austria)

2. Transepithelial PRK (T-PRK) Mode, Using Schwind Amaris 500 Hz Excimer Lasers (Adib-Moghaddam S. World Ophthalmology Congress, 16-20 February 2012, Abu Dhabi)

3. On line pachymetry outcome of ablation in aberration free mode TransPRK using SCHWIND AMARIS laser (Adib-Moghaddam S. ESCRS XXX, 8-12 september 2012, Milan)

4. Contrast Sensitivity and Visual Outcomes after Transepithelial Photorefractive Keratectomy (Adib-Moghaddam S. ASCRS.ASOA symposium and congress, April 19-23 2013, San Francisco)

5. Visual, Contrast Sensitivity outcomes and Aberration changes after Trans-PRK in high myopia: A 9-month follow-up study (Adib-Moghaddam S. The annual meeting of ISRS, Refractive Surgery Subspeciality day; April 2013; New Orleans)



6. Clinical outcomes of Transepithelial Photorefractive Keratectomy in Myopia 9 month follow up results (Adib-Moghaddam S. ESCRS XXXI, 5-9 October 2013, Amsterdam)

7. On-line pachymetry outcome of ablation in aberration free mode TransPRK (Adib-Moghaddam S et al. European journal of ophthalmology 24 (4), 483-489, 2014)

8. Visual, contrast sensitivity outcomes and aberration changes after transepithelial photorefractive keratectomy in high cylindrical refraction: 9 month follow-up results (Adib-Moghaddam S. 18th ESCRS Winter Meeting, 14-16 February 2014, Ljubljana)

9. Clinical Outcomes of Transepithelial Photorefractive Keratectomy in Hyperopia: Follow-up Study (Adib-Moghaddam S. The Annual ASCRS and ASOA Symposium and Congress,2014)

10. Effect of transepithelial photorefractive keratectomy on myopic eyes: visual quality and main factors predicting it (Adib-Moghaddam S. ESCRS XXXII, 13-17 Sep. 2014, London, UK)



11. Clinical Outcomes of Transepithelial Photorefractive Keratectomy In The

Correction Of Astigmatism : A Follow-up Study (Adib-Moghaddam S. American Academy

of Ophthalmology annual meeting, Oct. 17–18, 2014, Chicago)

12. Preoperative Visual Indices and Surgical Parameters That Influence Achieved

Visual Acuity after TransPRK (Adib-Moghaddam S. The annual meeting of ISRS,

Refractive Surgery Subspecialty day; October 2014; Chicago)

13. Subjective Quality of Vision Outcomes of Transepithelial Photorefractive

Keratectomy (Adib-Moghaddam S. 2015 ASCRS ASOA Symposium and Congress)

REFINED SINGLE-STEP TRANSPRK

Section II-b: TransPRK Research Group Publications


MODIFICATIONS

• Surgical Parameters

• Target refraction

• Optical zone determination

• Centration approach

• MMC regimen

• Post-surgical medication

• Iran regimen



1. Comparison of patients with low and high preoperative corrected distance visual acuity undergoing trans-epithelial photorefractive keratectomy in terms of surgical outcomes (Adib-Moghaddam S. 19th ESCRS Winter Meeting, 20-22 February 2014, Istanbul, Turkey)

2. Effect of trans-epithelial photorefractive keratectomy on myopic eyes higher order aberrations and main factors predicting it (Adib-Moghaddam S. ESCRS XXXIII, 5 - 9 Sept. 2015, Fira Gran Via, Barcelona)

3. Eighteen-month follow up results of single-step transepithelial photorefractive keratectomy in myopia in terms of qualitative and quantitative visual outcomes (Adib-Moghaddam S. The ISRS Annual Meeting, Refractive Surgery Subspecialty Day; 2015)

4. Demographic, surgical and preoperative optical indices that are associated with dynamic cyclotorsion correction throughout ablation in Transepithelial Photorefractive keratectomy (Adib-Moghaddam S. World Ophthalmology Congress 2016,Guadalajara, Mexico)

5. Transepithelial Photorefractive Keratectomy for Hyperopia: A 12-Month Bicentral Study (Adib-Moghaddam S et al. Journal of Refractive Surgery 32 (3), 172-180;2016)



6. Comparison of single-step transepithelial photorefractive keratectomy with or without mitomycin C in mild-moderate myopia (Adib-Moghaddam S. ESCRS XXXIV, 10-14 Sept. 2016, Copenhagen, Denmark)

7. Single-step transepithelial photorefractive keratectomy in myopia and astigmatism: 18-month follow-up (Adib-Moghaddam S et al. Journal of Cataract & Refractive Surgery 42 (11), 1570-1578;2016)

8. Single-step transepithelial photorefractive keratectomy in high myopia: qualitative and quantitative visual functions (Adib-Moghaddam S et al. International journal of ophthalmology 10 (3), 445;2017)

9. Clinical outcomes of refined transepithelial photorefractive keratectomy in asymmetric astigmatism (Adib-Moghaddam S. 21th ESCRS Winter Meeting, February 2017,Maastricht, Netherlands)

10. Determinant Factors of Achieving “High Supervision” 1 Year After Refined Single -Step Trans-PRK (Adib-Moghaddam S. ASCRS ASOA Symposium and Congress 2017, Los Angles, 2017 May)



11. Visual outcomes of transepithelial photorefractive keratectomy in forme-fruste

keratoconus: 18-month follow-up (Adib-Moghaddam S, ESCRS XXXV, 7-11 October

2017, Feira Internacional de Lisboa, Portugal)

12. Identification of optimal optical zone to transitional zone ratio in refined single-

step transepithelial photorefractive keratectomy; The annual meeting of ISRS, Refractive

Surgery Subspecialty day; November 10 2017; New Orleans, USA


TRANSEPITHELIAL PHOTOREFRACTIVE KERATECTOMY FOR HYPEROPIA: A 12-MONTH BICENTRAL STUDY

1st clinical results of hyperopia correction by single-step TransPRK

• Purpose: To investigate the safety, efficacy, and stability of transepithelial photorefractive keratectomy

(PRK) for hyperopia with or without mild to moderate astigmatism.

• Conclusion:

Single-step transepithelial PRK with the Amaris 500-Hz excimer laser:

Conventional method provided reasonable outcomes.

Refined method provided promising outcomes

Journal of Refractive Surgery 32 (3), 172-180;2016.


SINGLE-STEP TRANSEPITHELIAL PHOTOREFRACTIVE KERATECTOMY IN MYOPIA AND ASTIGMATISM: 18-MONTH FOLLOW-UP

The longest prospective follow-up results ever published

• Purpose: To evaluate the long-term quantitative and qualitative optical outcomes of refined single-

step transepithelial photorefractive keratectomy (PRK) to correct myopia and astigmatism.

• Conclusion:

Refined Trans-PRK in Myopia and Astigmatism correction:

Is safe and efficient. Improves refraction and quality of vision.

Vector analysis indicated promising results of astigmatism correction by this technique.

Journal of Cataract & Refractive Surgery 42 (11), 1570-1578;2016.


PAPERS UNDER REVISION / REVIEW

• Comparison of single-step trans-epithelial photorefractive keratectomy with or without

Mytomycin-C in mild-moderate myopia (Under Revision)

• Age, visual axis, and visual function associate with ocular cyclotorsion in single-step

transepithelial photorefractive keratectomy (Under Review)

• Determinant Factors of Quality of Vision after Transepithelial Photorefractive

Keratectomy in Myopia (Under Review)

• Predicting Supervision achievement after Transepithelial Photorefractive Keratectomy

in Myopia (Under Review)

OTHER PUBLICATIONS ON-PAR WITH OUR RESULTS

Section III


OTHER PUBLICATIONS AT A GLANCE

1. Consecutive myopia correction with transepithelial versus alcohol-assisted photorefractive keratectomy in contralateral eyes: One-year results (Luger MH et al. Consecutive myopia correction with transepithelial versus alcohol-assisted photorefractive keratectomy in contralateral eyes: one-year results. Journal of Cataract & Refractive Surgery. 2012 Aug 31;38(8):1414-23.)

2. Transepithelial photorefractive keratectomy mode using SCHWIND -ESIRIS excimer laser: initial clinical results (Wang DM et al. Transepithelial photorefractive keratectomy mode using SCHWIND-ESIRIS excimer laser: initial clinical results. International journal of ophthalmology. 2012;5(3):334.)

3. Comparison of single-step reverse transepithelial all-surface laser ablation (ASLA) to alcoholassisted photorefractive keratectomy (Aslanides IM et al. Comparison of single-step reverse transepithelial all-surface laser ablation (ASLA) to alcohol-assisted photorefractive keratectomy. Clinical ophthalmology (Auckland, NZ). 2012;6:973.)

4. A Clinical and Confocal Microscopic Comparison of Transepithelial PRK and LASEK for Myopia (Korkmaz et al. A clinical and confocal microscopic comparison of transepithelial PRK and LASEK for myopia. Journal of ophthalmology. 2014 Jul 10;2014.)

5. A Clinical and Confocal Microscopic Comparison of Transepithelial PRK and LASEK for Myopia (Korkmaz et al. A clinical and confocal microscopic comparison of transepithelial PRK and LASEK for myopia. Journal of ophthalmology. 2014 Jul 10;2014.)

6. Single-step transepithelial asla (sChWinD) with mitomycin-C for the correction of high myopia: long term follow-up (Aslanides IM et al. Single-step transepithelial ASLA (SCHWIND) with mitomycin-C for the correction of high myopia: long term follow-up. Clinical Ophthalmology (Auckland, NZ). 2015;9:33.)

7. Comparison of Three Epithelial Removal Techniques in PRK: Mechanical, Alcoholassisted, and Transepithelial Laser (Shapira Y et al. Comparison of three epithelial removal techniques in PRK: mechanical, alcohol-assisted, and transepithelial laser. Journal of Refractive Surgery. 2015 Nov 6;31(11):760-6.)


OTHER PUBLICATIONS AT A GLANCE

8. Single-Step Transepithelial PRK vs Alcohol-Assisted PRK in Myopia and Compound Myopic Astigmatism Correction (Kaluzny BJ et al. Single-step transepithelial PRK vs alcohol-assisted PRK in myopia and compound myopic astigmatism correction. Medicine. 2016 Feb;95(6).)

9. Comparison of Postoperative Pain Following Laser-assisted Subepithelial Keratectomy and TranS-PRK : a Prospective, Random Paired Bilateral Eye Study (Wang D et al. Comparison of postoperative pain following laser -assisted subepithelial keratectomy and transepithelial photorefractive keratectomy: a prospective, random paired bilateral eye study. 眼科学报. 2016 Aug 30;29(3):155-9.)

10. Changes in posterior corneal elevations after combined trans-PRK and accelerated corneal collagen cross-linking: retrospective, comparative observational case series (Lee H et al. Changes in posterior corneal elevations after combined transepithelial photorefractive keratectomy and accelerated corneal collagen cross-linking: retrospective, comparative observational case series. BMC ophthalmology. 2016 Aug 8;16(1):139.)

11. Myopia correction with transepithelial photorefractive keratectomy versus femtosecondLassisted laser in situ keratomileusis: One-year case-matched analysis (Luger MH et al. Myopia correction with transepithelial photorefractive keratectomy versus femtosecond− assisted laser in situ keratomileusis: One-year case-matched analysis. Journal of Cataract & Refractive Surgery. 2016 Nov 30;42(11):1579-87.)

12. Trans advanced surface laser ablation (TransPRK) outcomes using SmartPulseTechnology (Aslanides IM et al. Trans advanced surface laser ablation (TransPRK) outcomes using SmartPulseTechnology. Contact Lens and Anterior Eye. 2017 Feb 28;40(1):42-6.)

13. Single-step transepithelial versus alcohol-assisted photorefractive keratectomy in the treatment of high myopia: a comparative evaluation over 12 months (Antonios R et al. Single-step transepithelial versus alcohol-assisted photorefractive keratectomy in the treatment of high myopia: a comparative evaluation over 12 months. British Journal of Ophthalmology. 2017 Aug 1;101(8):1106-12.)

WHAT DO WE CURRENTLY KNOW ABOUT SINGLE-STEP

TRANSPRK?

Section IV


TYPE OF REFRACTIVE ERROR

• Promising results in mild-moderate myopia and mixed myopic astigmatism

• Promising results in correction of astigmatism.

• Reasonable results in pure hyperopic or mixed hyperopic astigmatic eyes by

conventional single-step TransPRK.

• Promising results in high myopic eyes.


COMPARED TO OTHER MODALITIES

• All-laser assisted

• Faster

• Easier to perform than conventional PRK

• Less pain, less discomfort

• Less postoperative haze

• A faster healing time


COMPARED TO OTHER MODALITIES

• Comparable CDVA, UDVA, and safety outcomes between transepithelial PRK and

alcohol-assisted PRK

• Comparable refractive outcomes to LASIK and PRK, with relatively favorable visual

acuity outcomes in SCHWIND t-PRK with Mytomycin C for high myopia

• Single-step TransPRK vs LASEK for high myopia with or without astigmatism:

• Similar visual, refractive and safety

• Faster Visual rehabilitation, re-epithelialization and less pain in the early post-

operative period in Tran-PRK with “smart-pulse-technology” than conventional Trans-

PRK


REFINED SINGLE-STEP TRANSPRK: VISUAL ACUITY AND REFRACTION

• High predictability and efficacy in terms of visual acuity and refraction

• % eyes > 20/25 | mild-moderate myopia: 97% , mild-moderate hyperopia: 95%, high-myopia: 87%

• ±0.5 D predictability | mild-moderate myopia: 98%, mild-moderate hyperopia:100%, high-myopia: 97%

• In patients with low pre-op CDVA, one-step refined TransPRK could improve CDVA and refraction so that these indices were comparable with high CDVA group after the operation.

• Stable refraction achieved by 3rd postoperative month in myopic correction.

• 1 out of 3 myopic eyes achieve supervision 1 year after operation

• Determinant factors of achieving high supervision (one year after TransPRK):

• Preoperative higher UDVA, lower astigmatism, better contrast sensitivity

• Preoperative smaller pupil diameter

• Less peak laser fluence (J/cm2) • Female gender (trend of significance [p=0.08])


REFINED SINGLE-STEP TRANSPRK: QUALITY OF VISION

• Enhances subjective (questionnaire-based) and objective visual quality of patients

with various refractive errors

• Improve photopic and mesopic CS in in myopic correction with or without astigmatism.

• No clinically significant alterations of HOA


EFFECTS ON QUALITY OF VISION

• Main factors that govern postoperative quality of vision in myopic correction:


REFINED SINGLE-STEP TRANSPRK: OTHER FINDINGS

• Refined Single-Step TransPRK with or without MMC, in correction of myopic eyes with

total ablation depths ≤ 160 µm resulted in: Similar Efficacy, Stability and Rate of Haze

induction.

• Main factors that govern DCC during ablation:

• Age

• Visual axis (kappa locus)

• UDVA, CDVA, and contrast sensitivity


TECHNICAL FINDINGS

• Optimal OZ / TZ ratio in Refined single-step TransPRK based on postoperative contrast sensitivity results

• Ratio < 4 resulted in postoperative outcomes comparable to ratio 5-6

• Ratio >7 as well as ratio 4-5 resulted in better outcomes compared to ratio<4 and 5-6

• These results were adjusted for positive effect of absolute OZ value on postoperative CS.

• What to consider in applying OZ > 7

• K (D)

• CCT (µm)

• Ratio of CCT to Spherical Equivalent (µm/D)


REFINED SINGLE-STEP TRANSPRK RESULTS HIGHLIGHTS

• Promising results in mild-moderate myopia with or without astigmatism

• Promising vector analysis results for correction of mixed myopic astigmatism

• Promising results in hyperopia with or without astigmatism.

• Improving contrast sensitivity without notable induction of higher order aberrations.

• Supervision achievement (1 out of 3 eyes treated achieves UDVA ≥ 15/10)

• Efficacy and safety of refined TransPRK by AMARIS 500 laser in asymmetric

astigmatism correction

• Efficacy and safety of refined TransPRK by AMARIS 500 laser in FFKC

• No need for MMC in mild-moderate myopia correction.

Based on existing evidence provided by literature pooled data:

Better quantity and quality of vision by

Refined single-step TransPRK

compared to other laser-assisted modalities in

correction of different refractive errors.

Correcting

Myopia

Astigmatism High myopia

Less PAIN

Less HAZE

What does TransPRK provide us currently?

Faster re-epithelialization

Easier to perform

Correcting Better results for myopia Better results for astigmatism

HYPEROPIA Asymmetric astigmatism

FFKC

SuperVISION Less need for MMC

Improved CS No HOA induction

What in advance does Refined TransPRK offer?

Nostradamus

Almost 5 years ago, my comment in TransPRK LinkedIn group: It will become a MAINSTREAM…

https://www.linkedin.com/groups/4777984

TREND OF GLOBAL TRANSPRK SHARE IN LASER-ASSISTED

REFRACTIVE SURGERY (DATA FROM 10 CENTERS)

TRANSPRK PUBLICATION TREND

1999

2007

2016

First prospective clinical results of two-step TransPRK published

Amaris Launched; single-step TransPRK

2011 First clinical results of single-step TransPRK published

First results of Refined single-step TransPRK published

FUTURE CHALLENGES AND EXPECTATIONS

Section V


CHALLENGING CASES SUBJECT TO FURTHER CONSIDERATIONS

• Achieving higher levels of visual acuity and visual quality

• Thin cornea

• Less ablation profiles

• Post-RK

• Presbyopia eyes

• Forme-Fruste and clinical Keratoconus

• High astigmatism

• High myopic mixed astigmatism

• High hyperopic mixed astigmatism

• Conflict with multifocal lenses implantation

ACKNOWLEDGMENT

Section VI

MY SPECIAL GRATITUDE AND APPRECIATION.

HE MAKES PROFOUND CONTRIBUTIONS TO ON-GOING

PROGRESS OF THIS TECHNIQUE

Samuel Arba Mosquera PhD

THE GENIUS


ACKNOWLEDGMENT

• Current Members of our team

• Ghazzale Tefagh MD (Iran)

• Salar Tofighi MD (Iran)

• Ali A. Haydar MD (Lebanon)

• Marjan Razi Khosroshahi MD (Iran)

• Ali Sanjari Moghaddam MD ( Iran)


ACKNOWLEDGMENT

• Past Members of our team

• Niloofar Hoorshad (Iran)

• Elena Qotbi (Iran)

• Fatemeh Adili-Aghdam ( USA)

• Amirhooshang Omidvari (Netherlands)

• Bahram Salmanian (USA)

• Medi Aslani (USA)

• Farsad Noorizadeh (Iran)

Thank you for your kind attention

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