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Safety and effectiveness of 20G Sutureless Pars plana vitrectomy: a prospective study at Sarojini Devi Hospital, Hyderabad.

INTRODUCTION: Pars plana vitrectomy (PPV) is a surgical procedure that involves removal of vitreous gel from the eye and the instruments are introduced into the eye through the pars plana. 20G Conventional Vitrectomy is a standard technique for Vitreo retinal surgery since its inception in 1970 and is accepted worldwide. (1) Conjunctiva is opened, three sclerotomy ports are made with MVR blade by a stab incision inferotemporally, superotemporally and superonasally. Infusion cannula is inserted and sutured to the inferotemporal sclerotomy port and remaining two sclerotomy ports are used for endoillumination and vitrectomy cutter. In 2002, Fujii et al introduced 25G vitrectomy with instruments of lumen diameter 0.5mm. Self-retained trocars are used for infusion cannula and other instruments. The trocars are inserted trans-conjunctivally and trans-sclerally and remained in place during the entire surgical procedure without the need for suturing them to sclera. (2) In 2004, 23G vitrectomy with instruments of lumen diameter 0.65mm were developed by Eckhardt et al. (3)

The quest to find new ways to shorten surgical time and minimize trauma to the eye led to the development of 20G sutureless technique by Chen et al in 1996, (4) where a tunnel incision is used instead of a stab incision used in Conventional 20G vitrectomy and there by incision is made self-sealing and left without sutures.

Yeshuran et al reported that 33 out of 35 eyes that underwent 20G sutureless vitrectomy had uneventful operations and only 2 eyes required suture placement at the end of the surgery. (5,6) Saad et al concluded from the 183 20G Sutureless sclerotomies performed, 10(6%) required suture placement. (7) Kim et al reported that in a series of 164 20G sutureless Vitrectomies, suture placement at the end of the procedure was required in 63 (38%) patients to close leaking sclerotomies. (8) In a comparative series of 21 consecutive eyes undergoing 20G sutureless Vitrectomies using self-sealing wedge shaped pars plana sclerotomies, Theelan et al reported no cases of hypotony. (9)

In a retrospective case series study on 20G sutureless Vitrectomies by Sangeet Mittal et al on 53 eyes of 45 patients, 2 patients had post-operative hypotony and 2 patients required suturing at the end of the surgery. (10)

Indications of Pars Plana Vitrectomy:

1. Macular Diseases: Macular epi-retinal membrane, Vitreo macular traction (VMT) syndrome, Macular Holes.

2. Complications of Diabetic Retinopathy: Vitreous hemorrhage, Tractional RD, Combined tractional and rhegmatogenous RD, Premacular subhyaloid haemorrhage.

3. Retinal Detachment.

4. Post-operative Endophthalmitis.

AIMS AND OBJECTIVES OF THE STUDY: To study the safety and effectiveness of 20G Sutureless PPV by comparing the change in BCVA and Intra ocular pressure in both the groups after surgery;

* To study the post-operative rehabilitation in both the groups and

* To study complications, if any like Endophthalmitis, Choroidal detachment, in both the groups.

MATERIALS AND METHODS: This study was a prospective comparative interventional case series study of 40 eyes of 40 patients, who underwent Pars Plana Vitrectomy for various indications like Non absorbing Vitreous Hemorrhage, Diabetic Macular edema,, Nucleus/IOL drop, Proliferative Vitreo Retinopathy, Primary Rhegmatogenous RD in a tertiary care centre, by a single surgeon between November 2011 to May 2013 were selected.

Patients were divided into 2 groups;

1. Patients undergoing Sutureless 20G vitrectomy.

2. Patients undergoing Conventional Sutured 20G vitrectomy.

Patients were explained about the diagnosis, various treatment options and possible complications and prognosis of the condition before enrolment.

Inclusion Criteria:

1. Patients above 20 years of age.

2. Patients undergoing vitrectomy for various indications as a primary procedure.

Exclusion Criteria

1. Patients with thin sclera.

2. Patients with corneo scleral injuries & retained intraocular foreign bodies.

3. Patients with repeated surgical procedures.

4. Patients with Glaucoma.

Evaluation included complete comprehensive ocular examination at baseline and at each follow up visit.

1. Slit lamp examination of anterior and posterior segment (Using 90D lens).

2. BCVA by Snellen's chart.

3. Indirect Ophthalmoscopy.

4. IOP with Goldmann applanation tonometry.

5. B-Scan (When required).

6. OCT (When required).

OBSERVATIONS AND ANALYSIS: The total no of patients included in the study were 40. These patients were divided into two groups:

1. 20 cases underwent Sutureless 20G Pars Plana Vitrectomy.

2. 20 cases underwent Sutured 20G Pars Plana Vitrectomy.

The follow up period for both the groups was 6 months.

DEMOGRAPHIC PROFILE: Graph 1: Gender distribution in both the groups:

                                            MALES   FEMALES

GENDER DISTRIBUTION IN SUTURED 20G PPV        14      6
GENDER DISTRIBUTION IN SUTURELESS 20G PPV     12      8

Note: Table made from pie chart.

GENDER COMPARISON BETWEEN TWO GROUPS

                                            MALES   FEMALES

SUTURED 20G PPV                               14      12
SUTURELESS 20G PPV                             6       8

Note: Table made from bar graph.


The mean Age of the patients in Sutureless 20G PPV was 49.65 [+ or -] 13.57 yrs Most of the patients falling in the age group of 40-59 years.

The mean age of patients in Sutured 20G PPV was 51.15 [+ or -] 10.68 years, Most of the patients belonging to age group of 40-59 years.

The distribution of cases in both the groups were, In Sutured 20G Group, there were 2 cases of Traumatic Vitreous Hemorrhage, 3 cases of Diabetic Vitreous Hemorrhage, 3 cases of Rhegmatogenous RD, 7 cases of Diabetic Tractional RD, 4 cases of Full thickness macular hole and 1 case of Endophthalmitis.

In Sutureless 20G group, there were 3 cases of Traumatic VH, 4 cases of Diabetic Vitreous hemorrhage, 4 cases of Rhegmatogenous RD, 5 cases of Diabetic Tractional RD, 3 cases of Full thickness Macular hole, 1 case of Endophthalmitis.

INTRA OCULAR PRESSURE: The average preoperative IOP in Sutureless 20G PPV was 15.9 [+ or -] 2.19 mm Hg.

The mean baseline IOP in 20G Sutured group changed from 15.6 [+ or -] 2.47mm Hg to 15.3 [+ or -] 1.49mm Hg. The difference between the pre op and day 1 post op IOP is not statistically significant. The difference between the mean IOP in Sutured 20G PPV remained statistically insignificant on all follow up visits compared to mean baseline preoperative IOP (p>0.05).There were no cases of Hypotony in Sutured 20G PPV.

The mean base line IOP in both the groups was compared and there was no statistically significant difference between them. The mean IOP on all follow up visits also did not differ in both the groups (Statistically insignificant difference between them.i.e, p>0.05)

VISUAL ACUITY:

The mean base line Log Mar BCVA in Sutureless 20G PPV was 1.61 [+ or -] 0.26. The mean base line Log Mar BCVA in Sutured 20G PPV was 1.57 [+ or -] 0.32. In Sutureless 20G Group, The mean Log Mar Visual acuity compared to the pre op levels changed significantly since 1 week and remained significant on all subsequent follow up visits.

There was no difference observed in the change in BCVA on all follow up visits in both the groups. The difference remained statistically insignificant (p>0.05)

PAIN SCORE: When asked from 0-10 to grade the pain according to Fekrat et al (11), the mean pain score on day 1 in Sutureless 20G PPV was 2.7 [+ or -] 0.7.

The mean pain score in Sutured 20G PPV on Day 1 was 5.2 [+ or -] 1.2. The difference between the pain scores in 2 groups was statistically significant (p<0.05).The difference in the pain between both the groups remained statistically significant at all follow up visits. The pace of slowdown in the pain also remained higher in Sutureless 20G PPV group.

CHEMOSIS: It is graded from 0-3 depending on the no of quadrants of the eye involved.

* The mean Chemosis score on Day 1 in Sutureless 20G PPV was 1.35 [+ or -] 0.48.

* The mean Chemosis score on Day 1in 20G Sutured PPV was 2.5 [+ or -] 0.51.

* The mean Chemosis score on all follow up visits remained less in Sutureless 20G PPV group.

One case in Sutureless 20G group required suturing at the end of the surgery as the wound integrity was doubtful. No other complications like lens touch, Endophthalmitis were observed in both the groups.

DISCUSSION: Suture less 20G PPV is a modified variant technique of 20G Conventional Vitrectomy. It causes minimal surgical trauma to conjunctiva and Tenon's capsule. Post-operative inflammation and patient discomfort were reduced compared to the Sutured 20G Pars plana Vitrectomy.

One patient (5%), out of 20 patients included in Sutureless 20G PPV required suture at the end of surgery in our study.

In our study, BCVA improved post operatively compared to preoperative BCVA in both the groups. The mean BCVA 3 months post operatively in Suture less 20G group was 0.90 [+ or -] 0.18, in Sutured 20G group was 0.92 [+ or -] 0.22. There was no statistically significant difference in the improvement of BCVA between both the groups i.e., there was improvement in BCVA in both the groups after surgery.

The pain score on Day 1 in Suture less 20G group was 2.7 [+ or -] 0.7. The pain score on Day 1 in Sutured 20G PPV was 5.2 [+ or -] 1.2. The p value between both the groups was statistically significant (p<0.05).The p value for pain on all subsequent follow up visits was statistically significant between both the groups. This shows that less pain was experienced by the patients in Suture less group compared to Sutured 20G PPV. The chemosis observed in Suture less 20G PPV group on Day 1 was 1.35 [+ or -] 0.489 and in the Sutured 20G group on Day 1, it is 2.5 [+ or -] 0.51. The difference in the Chemosis between both the groups was statistically significant. The chemosis observed on subsequent follow up visits was less in the Suture less 20G PPV compared to Sutured 20G PPV.

CONCLUSION: The results of our study show that 20G Suture less Pars plana Vitrectomy is as effective as 20G sutured PPV with good safety profile. There were 2 cases of Hypotony which normalized in 3 days. There was no statistical difference in the mean post-operative day 1 IOP compared to mean preoperative IOP in both the groups. The BCVA improved in both the groups and there was no statistical difference between the two groups. The pain and chemosis experienced by 20G Suture less group was statistically less than the pain and chemosis experienced by 20G sutured group. It makes the surgery well tolerated by the patients due to reduced post-operative inflammation and facilitates early post-operative rehabilitation of the patients. However, a Small percentage of cases may require suture for better wound integrity.

20G Sutureless Pars Plana Vitrectomy is an economical and safe procedure for various indications of PPV. It can be considered as a viable option between Conventional 20G PPV and 23G, 25G PPV. However, a study with a larger sample size is required to determine the safety for a wider acceptance of the procedure.

DOI:10.14260/jemds/2015/1942

BIBLIOGRAPHY:

(1.) Machemer R, Buettner H, Norton EW, Parel JM. Vitrectomy: A pars plana approach. Trans Am Acad Ophthalmol Otolaryngol 1971; 75: 813-20.

(2.) Fujii GY, De Juan Jr. E, Humayun MS, Pieramici DJ, Chang TS, Awh C et al. A new 25 gauge instrument system for transconjunctival suture less vitrectomy surgery. Ophthalmology 2002; 109: 1807-1813.

(3.) Eckardt C. Transconjunctival suture less 23 gauge vitrectomy. Retina 2005; 25: 208-211.

(4.) Chen JC. Suture less pars plana vitrectomy through self-sealing sclerotomies. Arch Ophthalmol 1996; 114: 1273-75.

(5.) Rishi. P Sengupta S. 20G Suture less Vitrectomy review article, World journal of Retina and Vitreous, May-August 2011; 1(1): 37-42.

(6.) Yeshuran I, Rock T, Bartov E. Modified suture less sclerotomies for parsplana vitrectomy.Am J Ophthalmol 2004; 138: 866-67.

(7.) Saad A, Assi A. Modified 20 gauge sutureless single step sclerotomies for pars plana vitrectomy. Retina 2009; 29: 848-53.

(8.) Kim JE, Shah SN, Choi DL, et al. Transconjunctival 20 gauge pars plana vitrectomy using a single entry cannulated sutureless system.Retina 2009; 29: 1294-98.

(9.) Theelen T, Verbeek AM, Tilanus MA, van den Biesen PR.A novel technique for self-sealing, wedge shaped pars plana sclerotomies and its features in ultrasound biomicroscopy and clinical outcome. Am J Ophthalmol 2003; 136: 1085-92.

(10.) Mittal S. 20G Transconjunctival vitrectomy-Possibility and limitations, AIOS Proceedings 2010, Retina Vitreous session IV, 657.

(11.) Fekrat S, Elsing SH, Raja SC, et al: Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina 2001; 21: 627-32.

Rajalingam Vairagyam [1], Karunakar B. [2], Pasyanthi B. [3], B. Y. Babu Rao [4], Rita Bahadur Shaw [5]

AUTHORS:

[1.] Rajalingam Vairagyam

[2.] Karunakar B.

[3.] Pasyanthi B.

[4.] B. Y. Babu Rao

[5.] Rita Bahadur Shaw

PARTICULARS OF CONTRIBUTORS:

[1.] Associate Professor, Department of Ophthalmology, Sarojini Devi Eye Hospital, Hyderabad.

[2.] Associate Professor, Department of Ophthalmology, Sarojini Devi Eye Hospital, Hyderabad.

[3.] Fellow, Department of Community Ophthalmology, LVPEI.

FINANCIAL OR OTHER COMPETING INTERESTS: None

[4.] Assistant Professor, Department of Ophthalmology, Sarojini Devi Eye Hospital, Hyderabad.

[5.] Consultant, Department of Ophthalmology, Rishab Eye Centre, Hyderabad.

NAME ADDRESS EMAIL ID OF THE CORRESPONDING AUTHOR:

Dr. Rajalingam Vairagyam, # 35-60/1, G. K. Colony, Sainikpuri Post, Secunderabad, Hyderabad-500094, Telangana State.

E-mail: rajalingamdr@yahoo.co.in

Date of Submission: 10/09/2015.

Date of Peer Review: 11/09/2015.

Date of Acceptance: 19/09/2015.

Date of Publishing: 26/09/2015.

Table 1: IOP Change in Sutureless 20G PPV

IOP             SUTURELESS 20G PPV
           Mean [+ or -] SD      p value

Pre op     15.9 [+ or -] 2.19
Day 1      14.6 [+ or -] 3.16    0.13
1 week     15.3 [+ or -] 2.17    0.38
1 month    15.5 [+ or -] 1.39    0.68
3 months   15.9 [+ or -] 1.20    0.99
6 months   16.2 [+ or -] 1.28    0.59

Table 2: IOP Change in Sutured 20G PPV

IOP        SUTURED 20G PPV
           Mean [+ or -] SD     p value

Pre op     15.6 [+ or -] 2.47
Day 1      15.3 [+ or -] 1.86    0.64
1 week       15 [+ or -] 2.20    0.40
1 month    15.7 [+ or -] 1.49    0.87
3 months   15.6 [+ or -] 2.11    0.99
6 months   15.7 [+ or -] 2.07    0.89

Table 3: IOP Comparison between both the groups

IOP        SUTURELESS 20G PPV     SUTURED 20G PPV       P Value
           Mean [+ or -] SD       Mean [+ or -] SD

Pre op      15.9 [+ or -] 2.19    15.6 [+ or -] 2.47    0.68
Day 1       14.6 [+ or -] 3.16    15.3 [+ or -] 1.49    0.27
1 week      15.3 [+ or -] 2.17      15 [+ or -] 2       0.65
1 month     15.5 [+ or -] 1.39    15.7 [+ or -] 1.49    0.66
3 months    15.9 [+ or -] 1.20    15.6 [+ or -] 2.11    0.58
6 months    16.2 [+ or -] 1.28    15.7 [+ or -] 2.07    0.36

Table 4: Suture less 20G PPV-Change in BCVA

               Suture less 20G PPV
Log Mar BCVA   MEAN [+ or -] SD        p value

PRE OP          1.61 [+ or -] 0.26
DAY 1           1.53 [+ or -] 0.27     0.34
1 WEEK          1.18 [+ or -] 0.22     0.0001
1 MONTH         0.98 [+ or -] 0.22     0.0001
3 MONTHS        0.90 [+ or -] 0.18     0.0001
6 MONTHS        0.88 [+ or -] 0.20     0.0001

Table 5: Change in BCVA in Sutured 20G PPV

           Sutured 20G PPV
           MEAN [+ or -] SD     p value

PRE OP     1.57 [+ or -] 0.32
DAY 1      1.48 [+ or -] 0.28   0.48
1 WEEK     1.14 [+ or -] 0.25   0.0001
1 MONTH    1.03 [+ or -] 0.25   0.0001
3 MONTHS   0.92 [+ or -] 0.22   0.0001
6 MONTHS   0.93 [+ or -] 0.22   0.0001

Table 6: Comparison of Change in BCVA in both the groups

Log Mar BCVA   SUTURELESS 20G PPV   SUTURED 20G PPV      p value

Pre op         1.61 [+ or -] 0.26   1.57 [+ or -] 0.32    0.65
Day 1          1.53 [+ or -] 0.25   1.48 [+ or -] 0.28    0.56
1 week         1.18 [+ or -] 0.22   1.14 [+ or -] 0.25    0.56
1 month        0.98 [+ or -] 0.12   1.03 [+ or -] 0.25    0.40
3 months       0.90 [+ or -] 0.18   0.92 [+ or -] 0.22    0.74
6 months       0.88 [+ or -] 0.20   0.93 [+ or -] 0.22    0.47

Table 7: Comparison of Pain score between both the groups

Pain score   20G Suture less PPV   20G Sutured PPV   P value

Day 1         2.7 [+ or -] 0.7     5.2 [+ or -] 1.2    <0.001
1 week        1.8 [+ or -] 0.7     4.0 [+ or -] 0.9    <0.001
1 month       0.7 [+ or -] 0.7     3.4 [+ or -] 1.0    <0.001
3 months      0.1 [+ or -] 0.3     1.6 [+ or -] 0.8    <0.001
6 months      0.0 [+ or -] 0.0     1.6 [+ or -] 0.8     0.001

Table 8: Comparison of Chemosis between both the groups

Chemosis   Suture less 20G PPV   Sutured 20G PPV       p value

Day 1       1.35 [+ or -] 0.489    2.5 [+ or -] 0.51   <0.001
1 week      0.55 [+ or -] 0.51     1.7 [+ or -] 0.65   <0.001
1 month             0              0.7 [+ or -] 0.47   <0.001
3 months            0              0.3 [+ or -] 0.45    0.006
6 months            0                     0

Graph 2: Suture less 20G PPV-Age Distribution

20-39 yrs   4
40-59 yrs   11
60-79 yrs   5

Note: Table made from bar graph.

Graph 3: Sutured 20G PPV-Age distribution

20-39 yrs   3
40-59 yrs   13
60-79 yrs   4

Note: Table made from bar graph.

Graph 4: Age comparison between both the groups

            SUTURED 20G PPV   SUTURELESS 20G PPV

20-39 yrs       3                 4
40-59 yrs       13                11
60-79 yrs       4                 5

Note: Table made from bar graph.

Graph 5: Sutured 20G PPV-Case Distribution

TRAUMATIC VH                  2
DIABETIC VH                   3
RHEGMATOGENOUS RD             3
DIABETIC TRACTIONAL RD        7
FULL THICKNESS MACULAR HOLE   4
ENDOPHTHALMITIS               1

Note: Table made from pie chart.

Graph 6: Sutureless 20G PPV-Case Distribution

TRAUMATIC VH                  3
DIABETIC VH                   4
RHEGMATOGENOUS RD             4
DIABETIC TRACTIONAL RD        5
FULL THICKNESS MACULAR HOLE   3
ENDOPHTHALMITIS               1

Note: Table made from pie chart.

Graph 7: Comparison of Case Distribution between both the groups

                              SUTURED 20G PPV   SUTURELESS 20G PPV

TRAUMATIC VH                      3                 2
DIABETIC VH                       4                 3
RHEGMATOGENOUS RD                 4                 3
DIABETIC TRACTIONAL RD            5                 7
FULL THICKNESS MACULAR HOLE       3                 4
ENDOPHTHALMITIS                   1                 1

Note: Table made from bar graph.

Graph 8: IOP change in Suture less 20G PPV

           IOP

PRE OP     15.9
DAY 1      14.8
1 WEEK     15.3
1 MONTH    15.5
3 MONTHS   15.9
6 MONTHS   16.2

Note: Table made from line graph.

Graph 9: IOP change in Sutured 20G PPV

           IOP

PRE OP     15.6
DAY 1      15.3
1 WEEK     15
1 MONTH    15.6
3 MONTHS   15.6
6 MONTHS   15.9

Note: Table made from line graph.

Graph 10: IOP Comparison between both the groups

           1OP    IOP

PRE OP     15.6   15.9
DAY 1      15.3   14.8
1 WEEK     15     15.3
1 MONTH    15.6   15.5
3 MONTHS   15.6   15.9
6 MONTHS   15.9   16.2

Note: Table made from line graph.

Graph 13: Comparison of change in BCVA in both the groups

           SUTURED 20G   SUTURELESS 20G

PRE OP        1.57           1.61
DAY 1         1.48           1.53
1 WEEK        1.14           1.18
1 MONTH       1.03           0.98
3 MONTHS      0.92           0.9
6 MONTHS      0.93           0.88

Note: Table made from line graph.

Graph 14: Change in Pain score in Sature less 20G PPV

           SUTURELESS 20G PPV

DAY 1      2.7
1 WEEK     1.7
1 MONTH    0.7
3 MONTHS   0.1
6 MONTHS   0

Note: Table made from line graph.

Graph 17: Comparison of Chemosis between both the groups

           SUTURELESS 20G PPV   SUTURED 20G PPV

DAY 1          1.35                 2.5
1 WEEK         0.55                 1.7
1 MONTH        0                    0.7
3 MONTHS       0                    0.3
6 MONTHS                            0

Note: Table made from line graph.
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Title Annotation:ORIGINAL ARTICLE
Author:Vairagyam, Rajalingam; Karunakar, B.; Pasyanthi, B.; Rao, B.Y. Babu; Shaw, Rita Bahadur
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Clinical report
Date:Sep 28, 2015
Words:3316
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