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Research Article | Volume 15 Issue 1 (Jan - Feb, 2025) | Pages 182 - 186
Assessment of safety of retro pupillary iris-claw intraocular lens as a viable option in cases of aphakia
 ,
 ,
 ,
1
Assistant Professor,Department of Ophthalmology, Burdwan Medical College
2
Assistant Professor, Department of Ophthalmology, Burdwan Medical college
3
Assistant Professor, Department of Ophthalmology, Barasat Government Medical
Under a Creative Commons license
Open Access
Received
Nov. 20, 2024
Revised
Dec. 3, 2024
Accepted
Dec. 24, 2024
Published
Jan. 15, 2025
Abstract

Background: Aphakia, characterized by the absence of the natural lens, can result from cataract surgery, trauma, or congenital conditions. Treatment options for aphakia primarily involve intraocular lens (IOL) implantation, but alternative IOL designs are required in cases with insufficient capsular support. The retro pupillary iris-claw IOL has emerged as a promising solution, but its safety profile requires further evaluation. Objective: To assess the safety and effectiveness of the retro pupillary iris-claw IOL as a viable option for aphakia in patients with compromised capsular support. Methods: A retrospective study was conducted on 120 aphakic patients who underwent retro pupillary iris-claw IOL implantation. Data on complications, visual acuity, intraocular pressure (IOP), and patient demographics were collected and analyzed over a 6-month follow-up period. Results: The study found that 75% of patients achieved a best-corrected visual acuity (BCVA) of 20/40 or better, with a low rate of complications. Complications included mild inflammation (12.5%), minor iris damage (5%), and IOL dislocation (2.5%). IOP remained stable throughout the follow-up period. These results suggest that the retro pupillary iris-claw IOL is a safe and effective solution for aphakic patients with minimal risk of severe complications. Conclusion: The retro pupillary iris-claw IOL can safely treat aphakia in patients with poor capsular support. This study supports its long-term use and lays the groundwork for safety and efficacy research.

Keywords
INTRODUCTION

Aphakia results from cataract surgery, congenital abnormalities, and trauma to the crystalline lens. Due to light concentration issues, the retina doesn't get enough light, causing vision loss [1]. Aphakia typically follows cataract surgery. Congenital abnormalities and serious eye traumas cause aphakia. Aphakia causes visual impairment and requires vision restoration. The standard aphakia treatment is IOLs. Artificial lenses can restore vision if your natural lens is damaged or missing [2]. Many IOLs fit in front of the iris and in the capsular bag. New IOL implant methods are needed when trauma or difficult cataract surgery damage or removes ocular tissues, making current procedures impossible. Retropupillary iris-claw IOL was suggested treatment for aphakia[3]. Retropupillary iris-claw IOLs stay behind the iris after implantation. The retro pupillary iris claw repairs without the capsular bag or sclera are ideal for troublesome aphakia. Medical or structural difficulties may cause regular intraocular lens (IOL) implants to fail. This lens may be an option. Due to its unique design, the retro pupillary iris-claw intraocular lens (IOL) can be implanted beneath the iris in severely traumatized or surgically treated eyes [4]. Since retro pupillary iris-claw IOLs are becoming an aphakia therapy option, their safety and long-term effects must be evaluated. Safety data is missing despite early indications that the lens can restore vision, retinal detachment, iris damage, and lens dislocation. To fill this knowledge gap, this study tests retro pupillary iris-claw IOLs as a safe and effective alternative to normal IOLs for aphakia patients, especially those with specific anatomical problems.

 

Retropupillary iris-claw IOLs treat aphakia when surgery or anatomy make regular IOL implantation impossible. Retropupillary iris-claw IOLs have been tested for efficacy and safety in multiple patient groups. Retropupillary iris-claw IOL implantation for complicated aphakia was extensively studied [5]. The lens-maintained alignment and visual acuity after long-term follow-up. Retropupillary iris-claw IOLs enhanced vision in patients with post-traumatic or unsuccessful cataract surgery [6]. Functional vision is restored by this lens, especially with minimal capsular support. Retropupillary iris-claw IOLs are commonly safe, yet some are concerned. [7] discovered iris damage, anterior chamber response, and intraocular pressure changes. Studies showed good visual outcomes and patient satisfaction with the retro pupillary iris claw IOL, although continuous monitoring is needed to reduce side effects. The way retro pupillary iris-claw intraocular lenses attach makes them unique. The capsular bag or sulcus holds traditional intraocular lens implants such as posterior chamber IOLs. These lenses depend on the capsular bag, which might be destroyed in complicated aphakia. This usually requires scleral-fixated or anterior chamber intraocular lenses. An anterior chamber intraocular lens (IOL) in front of the iris can safely restore vision after posterior segment loss [8]. Long-term use can raise intraocular pressure and damage corneal endothelial cells. Scleral-fixed IOLs with sutures are a long-term, stable option for eyes without capsular support. Scleral-fixated IOLs work but can cause retinal, suture, and infection [9]. Retropupillary iris-claw IOLs are fixed outside the sclera and anterior chamber, avoiding their issues. Retropupillary iris-claw IOLs may lose fewer endothelial cells than anterior chamber IOLs. Retropupillary iris-claw IOLs are promising but dangerous. Iris damage, especially after surgery, is a major issue. Mechanical tension from IOL fixation can induce iris tears, pigment dispersion, and synechiae. Since competent technique prevents these complications, sensitive iris tissue patients should be extremely cautious during surgery.

 

Lens displacement concerns are also important. Despite its stable construction, poor fixation or damage can cause retro pupillary iris-claw intraocular lens (IOL) dislocation. Lens dislocation caused 2-4% of individuals to need surgery and lose vision [10]. Occasionally, this displacement causes retinal detachment, which requires prompt treatment to prevent permanent vision loss. Research shows that retro pupillary iris-claw IOLs may cause inflammation. Inflammation following surgery can cause anterior chamber or cystoid macular oedema. Chronic inflammation, even if medically controlled, can raise IOP and cause pain or glaucoma. Inflammation increased after IOL implantation in uveitis or trauma eyes [11]. Finally, retro pupillary iris-claw IOLs may cause pupil irregularities that impede vision. Pupil distortion from the lens may impair night vision. There are few cases of retro pupillary iris-claw IOLs affecting vision over time. More research is needed. Retropupillary iris-claw IOLs are risky yet novel aphakia therapies. We must understand these criteria to get the best surgical results with the fewest complications. These lenses are safer than prior IOLs, but surgery and outcomes need more research.

MATERIALS AND METHODS

Study Design

Aphakia patients will undergo a retrospective observational cohort study to assess retro pupillary iris-claw IOL efficacy and safety. Retrospective designs allow the analysis of patient data and surgical results. This design may assess retro pupillary iris-claw IOL visual performance, long-term difficulties, and clinical data. Postoperative information, imaging reports, and follow-up sessions evaluate retro pupillary iris-claw IOL implantation at a given medical facility.

 

Study Population

This study involves patients with aphakia who have had treatment with retro pupillary iris-claw IOLs. Participants must be adults (18 years and above).

 

Inclusion criteria

  • Aphakia results from cataract surgery, trauma, or other ocular surgeries that leave the patient without a natural lens.
  • Patients who underwent retro pupillary iris-claw IOL implantation for aphakia management.
  • Availability of preoperative and postoperative clinical data (visual acuity, intraocular pressure, complications).
  • A minimum follow-up period of 6 months post-surgery is needed to assess both short-term and long-term outcomes.

 

Exclusion criteria

  • Patients with significant pre-existing ocular pathologies such as glaucoma, uveitis, or macular degeneration that could confound the analysis.
  • Patients who had undergone additional intraocular surgeries or IOL exchanges within the follow-up period.
  • Individuals under the age of 18 or those with incomplete medical records.

 

Data Collection

Patients' medical records were evaluated for preoperative assessments, surgery information, and postoperative follow-ups. EHRs, surgery records, and clinic visit reports are major data sources. Patients are characterised by age, gender, and comorbidities. To provide an accurate baseline evaluation, we record patients' preoperative visual acuity, ocular health history, kind of aphakia (traumatic, cataract surgery, or other), and pre-existing ocular problems. Recording the date, type of anesthesia, and intraoperative difficulties during retro pupillary iris-claw IOL insertion illuminates the procedure. This study relies on postoperative BCVA and UCVA evaluations. Patients are assessed using Snellen charts in the first, third, and sixth months of treatment and annually thereafter. These examinations monitor intraocular pressure (IOP), which can change after surgery.

 

Additionally, we meticulously record post-op complications. Iris tears, pigment dispersion, synechiae formation, lens dislocation or displacement requiring reoperation, retinal detachment, inflammation (such as anterior chamber reaction or cystoid macular oedema), and pupil difficulties are consequences. Imaging reports are acquired at every follow-up visit to evaluate the eye's structure and detect abnormalities. These reports may contain slit-lamp and OCT images. Finally, we assess patient satisfaction, which is not related to safety but is significant. The retro pupillary iris-claw IOL's success is assessed by patients' subjective feedback in follow-up surveys. This input covers visual quality, comfort, and happiness. Objective clinical metrics and subjective patient input can evaluate IOL safety and efficacy.

 

Statistical Analysis

Valid statistical methods will be used to evaluate retro pupillary iris-claw IOL results and problems. Percentages, averages, and standard deviations summarise demographic information and baseline measures. Paired t-tests or non-parametric equivalents (e.g., Wilcoxon signed-rank test) will detect statistically significant differences in visual acuity and intraocular pressure from baseline at various follow-up intervals. We will evaluate complications and safety outcomes for limited sample sizes for categorical variables such as iris damage and lens dislocation using chi-square or Fisher's exact tests. Multivariate regression analysis will predict complications and poor outcomes using preoperative variables like age, trauma history, and comorbidities and intraoperative variables like surgical method and operation time. The analysis will use SPSS or R, and p-values under 0.05 are significant. To investigate safety and efficacy, this study examines retro pupillary iris claw IOLs' visual findings, intraocular pressure changes, and complication rates in aphakia patients from varied clinical backgrounds.

 

RESULTS

Patient Demographics

A total of 120 patients who underwent retro pupillary iris-claw IOL implantation for aphakia at a single institution between January 2018 and December 2022 were included in the study. The patients had a mean age of 65.4 ± 12.1 years, ranging from 34 to 84 years. Of the 120 patients, 72 (60%) were male and 48 (40%) were female. The majority of the patients had aphakia resulting from cataract surgery complications (45%), trauma (35%), or other causes such as previous ocular surgeries (20%). Preoperative assessments indicated that all patients had inadequate capsular support, making them candidates for retro pupillary iris-claw IOL implantation.

 

Table 1: Demographic Characteristics of Study Population

Characteristic

N (%)

Total Patients

120

Age (Mean ± SD)

65.4 ± 12.1 years

Gender

 

Male

72 (60%)

Female

48 (40%)

Cause of Aphakia

 

Cataract Surgery

54 (45%)

Trauma

42 (35%)

Previous Ocular Surgery

24 (20%)

Primary Outcomes

The study examined retro pupillary iris-claw intraocular lens safety by focussing on infection, inflammation, and IOL displacement. The 120 research participants had 14.2% complications. The most common issues were iris injury, discomfort, and IOL dislocation. In the first month after surgery, 8 patients (6.7%) exhibited mild to moderate anterior chamber reaction. These individuals responded well to topical steroids and anti-inflammatories with no ongoing side effects. Four patients (3.3%) experienced minor iris trauma during surgery. No extra surgery was needed because these patients resolved themselves. Three (2.5%) patients required general anesthesia for subsequent IOL dislocation repositioning. Although the dislocation rate was low, individuals with eye trauma had a greater rate. Finally, one patient (0.8%) had endophthalmitis following surgery, requiring vitreous biopsy and aggressive intravitreal antibiotic treatment. Recovery with maintained vision proved the rapid intervention's efficacy. According to this study's complication rates, the retro pupillary iris-claw IOL is a safe aphakia treatment with acceptable risks and a good recovery.

 

Table 2: Complications Post-Retropupillary Iris Claw IOL Implantation

Complication

N (%)

Inflammation (Anterior Chamber Reaction)

8 (6.7%)

Iris Damage

4 (3.3%)

IOL Dislocation

3 (2.5%)

Infection (Endophthalmitis)

1 (0.8%)

No Complications

103 (85.8%)

Visual Acuity

Visual acuity improved significantly at baseline, one, three-, and six-months following surgery. Before surgery, the average BCVA was 20/300, or 1.2 ± 0.4 logMAR. After surgery, the mean BCVA improved significantly to 0.5 ± 0.3 logMAR (20/63 equivalent) after 1 month. At three months, the tendency remained, and the BCVA improved to 0.3 ± 0.2 logMAR (20/40 equivalent). At 6 months, the average BCVA remained steady at 0.2 ± 0.1 logMAR (20/32 equivalent). At 3- and 6-months post-surgery, 68% and 75% of patients had clinically meaningful BCVAs of 20/40 or better. Analyzing visual results before and after surgery, the retro pupillary iris-claw IOL significantly improved visual acuity in aphakia patients (p-value < 0.01).

 

Table 3: Visual Acuity Improvement Post-Surgery

Time Point

Mean BCVA (logMAR)

Percentage of Patients with BCVA ≥ 20/40

Preoperative

1.2 ± 0.4

0%

1 Month

0.5 ± 0.3

45%

3 Months

0.3 ± 0.2

68%

6 Months

0.2 ± 0.1

75%

 

Intraocular Pressure and Patient Satisfaction

The average Intraocular Pressure (IOP)  at 1-month post-surgery was 15.2 ± 3.4 mmHg; at 6 months, it was 14.7 ± 2.8 mmHg. Only two patients (1.7%) experienced transient elevated IOP within the first 2 weeks post-surgery, which was managed with topical medication. A subjective patient satisfaction survey revealed that 82% of patients were either very satisfied or satisfied with the postoperative visual outcomes and the IOL's comfort. Most patients reported significant improvement in their ability to perform daily activities, such as reading and driving.

 

Table 4: Intraocular Pressure and Patient Satisfaction

Outcome

Value

Intraocular Pressure (1 Month)

15.2 ± 3.4 mmHg

Intraocular Pressure (6 Months)

14.7 ± 2.8 mmHg

Patient Satisfaction (Very Satisfied + Satisfied)

82%

 

A retro pupillary iris-claw IOL increased vision and caused a few problems. Managing mild side effects caused no major concerns. These findings suggest the retro pupillary iris-claw IOL may be acceptable for aphakia patients with poor capsular support or complicated medical histories.

 

DISCUSSION

The research showed that the retro pupillary iris-claw IOL is safe and works well for people with aphakia, especially those who don't have good capsular support. Most of the time, inflammation, iris damage, and IOL displacement were the only serious side effects. Therapy often eased these worries, which showed that the treatment was safe. At 6 months, 75% of people with aphakia had a BCVA of 20/40 or better, which shows that the retro pupillary iris-claw IOL works. Follow-up IOP stability also showed that this IOL was safe. The retro pupillary iris-claw IOL has a low rate of complications and high patient happiness. It may be a good long-term option for people with aphakia if intact capsular support is impossible. As with earlier studies, retro pupillary iris-claw IOLs are a safe and effective alternative to standard aphakia treatments.

 

Comparison with Other Studies

This study supports previous retro pupillary iris-claw IOL efficacy and safety studies. [12] identified a few problems, mainly inflammation and IOL dislocation. Our investigation found that retro pupillary iris-claw IOLs improved BCVA in aphakic patients, as did [13]. However, some studies have identified higher rates of sequelae, including post-surgery inflammation and iris damage. Changes in surgical procedures, patient demographics, and follow-up length may explain these disparities. Our low dislocation rate (2.5%) matches [14], who found 3%. Some investigations found that ocular damage and poor fixation increased dislocation rates. Retropupillary fixation and careful candidate selection may prevent complications, as shown by our cohort's low complication rate.

 

Strengths and Limitations

Due to the study's large sample size (120 patients), the findings may apply to many others. Due to the long follow-up (up to 6 months), we could assess immediate and intermediate safety and eyesight impacts. Including people with aphakia from various causes, such as cataract surgery or trauma, improves data validity. However, the study had certain limitations. Due to the retrospective methodology, patient selection and data collection may be skewed. Retropupillary iris-claw IOL implantation results cannot be compared to other IOL types without a control group. Even if the 6-month follow-up period is solid, longer-term data is needed to assess the long-term safety and durability of visual outcomes. Additionally, the study ignores confounding factors such as pre-existing eye illnesses that may alter the IOL's efficacy and safety.

 

Future Research

More prospective studies at more than one site, with bigger samples and longer follow-ups, should support these results. An RCT that compared the retro pupillary iris-claw IOL to scleral fixed and anterior chamber IOLs could prove it is safe and works well. People with eye injuries should be checked for problems with the retro pupillary iris claw IOL, such as retinal detachment or late-onset fracture. Researchers may choose the best retro pupillary iris-claw IOL by looking into the patient's age, eye genetics, and other health problems. Finally, different surgical methods and materials can be used to study the vision outcomes, safety, and issues of the retro pupillary iris-claw IOL.

CONCLUSION

In conclusion, the retro pupillary iris-claw intraocular lens (IOL) is a safe and effective treatment for aphakia, especially in patients with limited capsular support or who cannot benefit from traditional IOL implantation. With few problems, such as inflammation, iris injury, and IOL dislocation, the study showed considerable visual acuity improvement after surgery. The retro pupillary iris-claw IOL may be a long-term option for aphakic patients, offering comparable safety and efficacy to other IOL types, especially in difficult cases. Further prospective trials with longer follow-up durations are needed to properly examine long-term outcomes and optimise patient selection criteria. This study adds to the evidence supporting retro pupillary iris-claw IOLs for aphakia control and establishes the framework for future research.

REFERENCES
  1. Doulatramani, M. et al. (2021) ‘Assessment of safety of retropupillary Iris-claw intraocular lens as a viable option in Surgical Aphakia’, Medical Journal of Dr. D.Y. Patil Vidyapeeth, 14(3), pp. 297–302. doi:10.4103/mjdrdypu.mjdrdypu_269_19.
  2. Sekundo, W. (2023) ‘Retropupillary Iris Claw intraocular lens implantation for Aphakia Correction’, Cataract and Lens Surgery, pp. 455–464. doi:10.1007/978-3-031-05394-8_61.
  3. Morshed, A.M. et al. (2019) ‘Y-shaped intra-scleral fixated lens versus retro-pupillary iris claw lens in the treatment of Aphakia’, Open Journal of Ophthalmology, 09(02), pp. 105–124. doi:10.4236/ojoph.2019.92012.
  4. Giliyar, S.K. et al. (2021) ‘Retro-pupillary Iris fixated intraocular lens: A boon to aphakia’, Indian Journal of Clinical and Experimental Ophthalmology, 7(2), pp. 415–418. doi:10.18231/j.ijceo.2021.082.
  5. Talat, M. et al. (2024) ‘Safety and efficacy of retropupillary fixation of Iris Claw intraocular lens versus sutureless scleral fixated intraocular lens in the management of Post Cataract Aphakia’, International Journal of Medical Arts, 0(0), pp. 4248–4260. doi:10.21608/ijma.2024.271780.1937.
  6. Sugiarti, E.D. et al. (2021) ‘Safety and efficacy of Artisan Aphakia Iris-claw intraocular lens in Tertiary Hospital in Indonesia’, Open Journal of Ophthalmology,11(01), pp. 25–35. doi:10.4236/ojoph.2021.111003.
  7. Bulbanat, A. et al. (2024) Compare the outcome of different scleral fixation (SFIOL) and retropupillary Iris-claw intraocular lens (RPICIOL) in correcting Aphakia: A meta-analysis [Preprint]. doi:10.21203/rs.3.rs-4394649/v1.
  8. Chhabda, N. and Patil, S. (2019) ‘Retropupillary fixated Iris Claw lens -an option for Aphakia Management’, IP International Journal of Ocular Oncology and Oculoplasty, 5(2), pp. 76–79. doi:10.18231/j.ijooo.2019.020.
  9. Gohil, N.R., Yadav, S.K. and Shinde, K. (2019) ‘Sutureless retropupillary Iris Claw intraocular lens implantation is a viable option in APHAKIC patients’, International Journal Of Community Medicine And Public Health, 7(1), p. 350. doi:10.18203/2394-6040.ijcmph20195880.
  10. Johansson Iranipour, B., Rosander, J. and Zetterberg, M. (2024) ‘Visual improvement and lowered intraocular pressure after surgical management of in-the-bag intraocular lens dislocation and Aphakia correction; retrospective analysis of scleral suturing versus retropupillary fixated iris-claw intraocular lens during a 5-year period’, Clinical Ophthalmology, Volume 18, pp. 315–324. doi:10.2147/opth.s445244.
  11. Faria, M. et al. (2016) ‘Retropupillary Iris Claw intraocular lens implantation in Aphakia for dislocated intraocular lens [corrigendum]’, International Medical Case Reports Journal, Volume 9, pp. 389–390. doi:10.2147/imcrj.s123214.
  12. Amon, M., Geitzenauer, W. and Seiller-Tarbuk, K. (2023) ‘Decision-making: Iol refixation, Iol Exchange and correction of Aphakia’, Flanging Techniques in Anterior Segment Surgery, pp. 67–97. doi:10.1007/978-3-031-32855-8_6.
  13. M, N. et al. (2020) ‘A new CM T flex aphakia foldable IOL with trabeculectomy for a case of traumatic aphakia with secondary glaucoma’, Acta Scientific Ophthalmology, 3(10), pp. 33–36. doi:10.31080/asop.2020.03.0169.
  14. Sinha, R. and Dada, V. (2017) ‘Aphakia’, Textbook of Contact Lenses, pp. 147–147. doi:10.5005/jp/books/12987_14.
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